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Sangui Biotech, Inc. Intact-Pth (Parathyroid Hormone) Elisa

by Sangui Biotech, Inc.

510(k) K974306

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974306 Date23 Dec 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1520-2018 FDA Class III initiated 26 Oct 2016

    There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.

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  • Withdrawn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
CEW
Device Class
Class II
Regulation
21 CFR Part 862.1545
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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