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FDA 510(k)

COAG-A-MATE 2001

K-Number: K790323 · 1979-03-21

ApplicantGeneral Diagnostics
Decision Date1979-03-21
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAG-A-MATE 2001 is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1979-03-21 under 510(k) number K790323. 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 COAG-A-MATE 2001?

COAG-A-MATE 2001 is a medical device that received FDA 510(k) clearance on 1979-03-21. The listed applicant is General Diagnostics. The 510(k) number is K790323.

When did COAG-A-MATE 2001 receive FDA 510(k) clearance?

COAG-A-MATE 2001 received FDA 510(k) clearance on 1979-03-21, under 510(k) number K790323.

Who is the listed applicant for COAG-A-MATE 2001?

The FDA 510(k) record lists General Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COAG-A-MATE 2001?

The FDA product code for COAG-A-MATE 2001 is JPA.

Other records listing General Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K882663BARBITURATE ENZYME IMMUNOASSAY KITK872882CANNABINOID ENZYME IMMUNOASSAY KITK871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITK864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEK863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITK842307GENERAL DIAG. CEFONICID 30MCG ANTIMIC

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Related Devices (Code: JPA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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