Diagnostics 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 15, 2026, FDA's public records list Chembio Diagnostic Systems with 7 510(k) clearances. The most recent is a 510(k) clearance dated Jun 3, 2020: DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader.
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.
| Jun 3, 2020 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderK200506 · QFO | 510(k) clearances |
| Aug 14, 2001 | HCG STAT PAK ULTRA-FASTK011550 · JHI | 510(k) clearances |
| Aug 14, 2001 | SURE CHECK PREGNANCY TESTK011551 · LCX | 510(k) clearances |
| May 2, 2001 | SURE CHECK OVULATION PREDICTORK010244 · CEP | 510(k) clearances |
| Feb 12, 1999 | PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAYK981913 · LSR | 510(k) clearances |
| Jun 24, 1996 | SURE CHECK PREGNANCY TESTK961965 · LCX | 510(k) clearances |
| Dec 24, 1992 | HCG STAT-PAKK923925 · 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
