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Drug, Insurance, Urinalysis, Blood/Urine Test Kits

by Gbf Medical Group

510(k) K931474

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK931474 Date10 May 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 11 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  • Withdrawn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
KDW
Device Class
Class I
Regulation
21 CFR Part 864.3250
Advisory Committee
Pathology
FDA Decision
SESK Substantially Equivalent — Kit