Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Acro Biotech with 10 510(k) clearances. The most recent is a 510(k) clearance dated May 18, 2018: Acro HCG Pregnancy Rapid Test.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 18, 2018 | Acro HCG Pregnancy Rapid TestK180771 · LCX | 510(k) clearances |
| Feb 2, 2018 | ACRO HCG Pregnancy Rapid TestK172512 · LCX | 510(k) clearances |
| Aug 7, 2006 | ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000K060355 · DJC | 510(k) clearances |
| Jul 28, 2006 | ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000K060354 · JXM | 510(k) clearances |
| Jun 15, 2006 | ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100K053037 · DJG | 510(k) clearances |
| Jun 6, 2006 | ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000K053033 · DJC | 510(k) clearances |
| Jun 6, 2006 | ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000K053034 · LDJ | 510(k) clearances |
| May 5, 2006 | ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000K053035 · DIO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
