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FDA 510(k)

ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I

K-Number: K893783 · 1989-06-23

ApplicantAnalytical Control Systems, Inc.
Decision Date1989-06-23
Product CodeGIZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I 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 1989-06-23 under 510(k) number K893783. The device is classified under product code GIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I?

ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K893783.

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

ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893783.

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

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 I?

The FDA product code for ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I is GIZ.

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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: GIZ)

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.

K060968STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOWWortham Laboratories, Inc.K042941DADE BEHRING HEPARIN CALIBRATOR AND CONTROLSDade Behring, Inc.K023309CONTROL PLASMA NDade Behring, Inc.K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10Precision BiologicK003328ACCUCLOT CONTROL I, MODEL A4089Sigma Diagnostics, Inc.K001256CONTROL PLASMA NDade 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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