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Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt Controls for Coaguchek Pro System, Coaguchek P

by Roche Diagnostics/Boehringer Mannheim GmbH

510(k) K983892

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983892 Date13 Apr 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0813-03 FDA Unclassified (pre-2012) initiated 12 Mar 2003

    High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.

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  • Withdrawn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
JPA
Device Class
Class II
Regulation
21 CFR Part 864.5425
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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