Consumer health companyLabelled 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 its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Bionike Laboratories with 6 510(k) clearances. The most recent is a 510(k) clearance dated Dec 7, 1999: BIONIKE AQ PHENCYCLIDINE (PCP) TEST.
| Dec 7, 1999 | BIONIKE AQ PHENCYCLIDINE (PCP) TESTK993945 · LCM | 510(k) clearances |
| Aug 6, 1997 | AQ ONE STEP COCAINE TESTK972384 · DIO | 510(k) clearances |
| Jun 25, 1997 | BIONIKE AQ ONE STEP CANNABINOIDS (THC) TESTK971841 · LDJ | 510(k) clearances |
| Jun 6, 1997 | AQ OPIATES (MORPHINE) TESTK971361 · DJG | 510(k) clearances |
| Apr 25, 1996 | BIONIKE A/Q PREGNANCY TESTK960992 · JHI | 510(k) clearances |
| Dec 11, 1995 | BIONIKE A/Q PREGNANCY TESTK954901 · JHI | 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
