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FDA 510(k)

COAG-CONTROL

K-Number: K930923 · 1993-04-27

ApplicantAmerican Bioproducts Co.
Decision Date1993-04-27
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAG-CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1993-04-27 under 510(k) number K930923. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAG-CONTROL?

COAG-CONTROL is a medical device that received FDA 510(k) clearance on 1993-04-27. The listed applicant is American Bioproducts Co.. The 510(k) number is K930923.

When did COAG-CONTROL receive FDA 510(k) clearance?

COAG-CONTROL received FDA 510(k) clearance on 1993-04-27, under 510(k) number K930923.

Who is the listed applicant for COAG-CONTROL?

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

What is the FDA product code for COAG-CONTROL?

The FDA product code for COAG-CONTROL is GGC.

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Other records listing American Bioproducts 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.

K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZERK971519ASSERACHROM TPA TEST KITK964716STA LIATEST CONTROL [N]+[P] KITK964728STA-LIATEST D-DI TEST KITK964718STA D-DI CALIBRATOR KITK962675STA - LIATEST VWF TEST KIT

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Related Devices (Code: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, Inc.

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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