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Hemochek-A1C Sample Collection Kit

by Osborn Group, Inc.

510(k) K990899

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

34 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 NumberK990899 Date21 Dec 1999ClearedStatusActive

Recalls

34 recalls · FDA

  • 34 recalls, same reason

    • Terminated Z-0548-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0571-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0572-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0547-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0581-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0532-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0529-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0570-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0575-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0577-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0564-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0569-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0530-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0568-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0556-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0557-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0528-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0559-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0560-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0574-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0531-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0561-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0562-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0558-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0554-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0525-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0573-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0576-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0555-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0578-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0580-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0553-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0552-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011
    • Terminated Z-0550-2012 FDA Unclassified (pre-2012) initiated 9 Jan 2011

    Kits contain recalled Triad alcohol pads

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
LCP
Device Class
Class II
Regulation
21 CFR Part 864.7470
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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