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FDA 510(k)

ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II

K-Number: K893971 · 1989-07-25

ApplicantAnalytical Control Systems, Inc.
Decision Date1989-07-25
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Control Systems, Inc.. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K893971. 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 ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II?

ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K893971.

When did ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II receive FDA 510(k) clearance?

ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II received FDA 510(k) clearance on 1989-07-25, under 510(k) number K893971.

Who is the listed applicant for ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II?

The FDA 510(k) record lists Analytical Control Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II?

The FDA product code for ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II is GGC.

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Other records listing Analytical Control Systems, Inc. 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.

K961892SPECKTIN-LA TEST SETK941115ACS CARDIO-TROL CONTROLK940272ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLK940397ACS O DILVENT PROTEIN DILUTION MATRIXK930477ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATORK926012ACS APCT REAGENT, MODIFIED

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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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