510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090191Substantially Equivalent

Handylab Gbs Assay, Handylab Jaguar Instrument, Handylab DNA Extraction Strip, Handylab E3 Extraction Reagent, Handylab

Handylab, Inc., Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090191 is the FDA 510(k) clearance record for HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB, a class I device, cleared for Handylab, Inc. on under FDA product code NJR (Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test). FDA's definition for product code NJR reads: "A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status". FDA records list one 510(k) clearance for Handylab, Inc. As of , FDA records show no recalls naming K090191.

Clearance record

Decision date
Received
(485 days to decision)
Product code
NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Applicant
Handylab, Inc. 5230 S. State Rd., Ann Arbor MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NJR

Trailing 12 months

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

FDA records show no clearances under product code NJR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NJR, 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