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FDA 510(k)

IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT

K-Number: K800228 · 1980-02-21

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

Device Summary

IMMUNOP. ANTISMOOTH MUSCLE 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 K800228. The device is classified under product code DBE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT?

IMMUNOP. ANTISMOOTH MUSCLE 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 K800228.

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

IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT received FDA 510(k) clearance on 1980-02-21, under 510(k) number K800228.

Who is the listed applicant for IMMUNOP. ANTISMOOTH MUSCLE 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. ANTISMOOTH MUSCLE ANTIBODY KIT?

The FDA product code for IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT is DBE.

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Related Devices (Code: DBE)

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.

K810983ANTISMOOTH MUSCLE ANTIBODY TEST SYSImmuno-Products IndustriesK800820AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODYCalbiochem-Behring Corp.K790430MEDICA II-F-ASMA TEST KITMedica Corp.K771155ANTI-MITOCHONDRIALMeloy Laboratories, Inc.K760156TEST, (IVDP) SMOOTHMUSCLE ANTIBODYZeus Scientific, 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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