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FDA 510(k)

IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT

K-Number: K800229 · 1980-02-21

ApplicantClinical Sciences, Inc.
Decision Date1980-02-21
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT 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 1980-02-21 under 510(k) number K800229. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT?

IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT is a medical device that received FDA 510(k) clearance on 1980-02-21. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K800229.

When did IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT receive FDA 510(k) clearance?

IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT received FDA 510(k) clearance on 1980-02-21, under 510(k) number K800229.

Who is the listed applicant for IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT?

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 IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT?

The FDA product code for IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT is DBM.

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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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