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FDA 510(k)

GENERAL DIAGNOSTICS COAG-A-MATE XC

K-Number: K852843 · 1985-08-13

ApplicantWarner-Lambert Co.
Decision Date1985-08-13
Product CodeKQC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GENERAL DIAGNOSTICS COAG-A-MATE XC is the device name listed in this FDA 510(k) record. The listed applicant is Warner-Lambert Co.. It received FDA 510(k) clearance on 1985-08-13 under 510(k) number K852843. The device is classified under product code KQC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENERAL DIAGNOSTICS COAG-A-MATE XC?

GENERAL DIAGNOSTICS COAG-A-MATE XC is a medical device that received FDA 510(k) clearance on 1985-08-13. The listed applicant is Warner-Lambert Co.. The 510(k) number is K852843.

When did GENERAL DIAGNOSTICS COAG-A-MATE XC receive FDA 510(k) clearance?

GENERAL DIAGNOSTICS COAG-A-MATE XC received FDA 510(k) clearance on 1985-08-13, under 510(k) number K852843.

Who is the listed applicant for GENERAL DIAGNOSTICS COAG-A-MATE XC?

The FDA 510(k) record lists Warner-Lambert Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENERAL DIAGNOSTICS COAG-A-MATE XC?

The FDA product code for GENERAL DIAGNOSTICS COAG-A-MATE XC is KQC.

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Other records listing Warner-Lambert Co. 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.

K024160NEOSPORIN SCAR SOLUTIONK893452EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAMK870584O.P.T.(TM) OVULATION PREDICTION TESTK861510MULTILUMEN VIAPIC CENTRAL LINE CATHETERK852967GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISKK852689GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK

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Related Devices (Code: KQC)

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.

K882873FIELDTEX HEMATOXYLINAnatech, Ltd.K843619RETIC-SETR&D Systems, Inc.K841848RETIC-SETR&D Systems, Inc.K792550PONCEAU S STAIN SETElectrophoresis Corp. of AmericaK792496VOLU-SOL NMB RETICULOCYTE STAINVolu Sol Medical IndustriesK791007STAT DIFF STAINBioscientific

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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