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Chem-Chex

by Streck Laboratories, Inc. 2 variants

510(k) K913687

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK913687 Date19 Sep 1991ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0443-2011 FDA Unclassified (pre-2012) initiated 6 Oct 2010
    • Terminated Z-0440-2011 FDA Unclassified (pre-2012) initiated 6 Oct 2010
    • Terminated Z-0441-2011 FDA Unclassified (pre-2012) initiated 6 Oct 2010
    • Terminated Z-0442-2011 FDA Unclassified (pre-2012) initiated 6 Oct 2010
    • Terminated Z-0439-2011 FDA Unclassified (pre-2012) initiated 6 Oct 2010

    The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product.

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  • Withdrawn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
JJY
Device Class
Class I
Regulation
21 CFR Part 862.1660
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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