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Sangui Biotech, Inc. Calcitonin Elisa Kit

by Sangui Biotech, Inc.

510(k) K982491

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK982491 Date3 Sep 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0467-2015 FDA Class II initiated 18 Sep 2014

    A potential issue with false high values.

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  • Withdrawn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
JKR
Device Class
Class II
Regulation
21 CFR Part 862.1140
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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