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FDA 510(k)

COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P

K-Number: K983892 · 1999-04-13

ApplicantRoche Diagnostics/Boehringer Mannheim GmbH
Decision Date1999-04-13
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics/Boehringer Mannheim GmbH. It received FDA 510(k) clearance on 1999-04-13 under 510(k) number K983892. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P?

COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P is a medical device that received FDA 510(k) clearance on 1999-04-13. The listed applicant is Roche Diagnostics/Boehringer Mannheim GmbH. The 510(k) number is K983892.

When did COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P receive FDA 510(k) clearance?

COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P received FDA 510(k) clearance on 1999-04-13, under 510(k) number K983892.

Who is the listed applicant for COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P?

The FDA 510(k) record lists Roche Diagnostics/Boehringer Mannheim GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P?

The FDA product code for COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P is JPA.

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Other records listing Roche Diagnostics/Boehringer Mannheim GmbH as applicant

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Official Source

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