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

by Handylab, Inc.

510(k) K090191

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090191 Date27 May 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 10 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NJR
Device Class
Class I
Regulation
21 CFR Part 866.3740
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent