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FDA 510(k)

INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL

K-Number: K791749 · 1979-10-17

ApplicantClinical Sciences, Inc.
Decision Date1979-10-17
Product CodeDAA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL 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 1979-10-17 under 510(k) number K791749. 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 INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL?

INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K791749.

When did INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL receive FDA 510(k) clearance?

INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791749.

Who is the listed applicant for INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL?

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 INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL?

The FDA product code for INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL is DAA.

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Other records listing Clinical Sciences, Inc. as applicant

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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.K822911ANAZYME ANA PEROXIDASE TEST SYSTEMClinical 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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