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FDA 510(k)

ANAZYME ANA PEROXIDASE TEST SYSTEM

K-Number: K822911 · 1982-10-22

ApplicantClinical Sciences, Inc.
Decision Date1982-10-22
Product CodeDAA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANAZYME ANA PEROXIDASE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1982-10-22 under 510(k) number K822911. The device is classified under product code DAA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANAZYME ANA PEROXIDASE TEST SYSTEM?

ANAZYME ANA PEROXIDASE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1982-10-22. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K822911.

When did ANAZYME ANA PEROXIDASE TEST SYSTEM receive FDA 510(k) clearance?

ANAZYME ANA PEROXIDASE TEST SYSTEM received FDA 510(k) clearance on 1982-10-22, under 510(k) number K822911.

Who is the listed applicant for ANAZYME ANA PEROXIDASE TEST SYSTEM?

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

What is the FDA product code for ANAZYME ANA PEROXIDASE TEST SYSTEM?

The FDA product code for ANAZYME ANA PEROXIDASE TEST SYSTEM is DAA.

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Related Devices (Code: DAA)

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.

K832675ANA MICROZYME TEST SYS #1610Clinical Sciences, Inc.K831927ANTINUCLEAR ANTIBODY TEST KITBreit Laboratories, Inc.K830005IP SPECIFIC GDiagnostic Reagent Tech.K791749INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROLClinical Sciences, 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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