510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200506Substantially Equivalent

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

Chembio Diagnostic Systems, Inc., Medford NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200506 is the FDA 510(k) clearance record for DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader, a class II device, cleared for Chembio Diagnostic Systems on under FDA product code QFO (Zika Virus Serological Reagents). FDA's definition for product code QFO reads: "Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection...". FDA records list 7 510(k) clearances for Chembio Diagnostic Systems, from to . As of , FDA records show no recalls naming K200506.

Clearance record

Decision date
Received
(93 days to decision)
Product code
QFO Zika Virus Serological Reagents
Regulation
21 CFR 866.3935
Device class
Class II
Review panel
Microbiology
Applicant
Chembio Diagnostic Systems 3661 Horseblock Rd., Medford NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QFO

Trailing 12 months

FDA records hold no clearances under product code QFO in the trailing twelve months.

FDA records show no clearances under product code QFO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QFO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260