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Glucose (Hexokinase)

by Jas Diagnostics, Inc.

510(k) K011900

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011900 Date31 Jul 2001ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0827-2015 FDA Class II initiated 23 Oct 2014

    Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.

    • Terminated Z-1873-2014 FDA Class II initiated 7 Apr 2014 on shared 510(k) K011900

    JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
CFR
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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