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FDA 510(k)

CORITSOL PREMIX RIA KIT

K-Number: K842957 · 1984-09-14

ApplicantBiotecx Laboratories, Inc.
Decision Date1984-09-14
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORITSOL PREMIX RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biotecx Laboratories, Inc.. It received FDA 510(k) clearance on 1984-09-14 under 510(k) number K842957. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORITSOL PREMIX RIA KIT?

CORITSOL PREMIX RIA KIT is a medical device that received FDA 510(k) clearance on 1984-09-14. The listed applicant is Biotecx Laboratories, Inc.. The 510(k) number is K842957.

When did CORITSOL PREMIX RIA KIT receive FDA 510(k) clearance?

CORITSOL PREMIX RIA KIT received FDA 510(k) clearance on 1984-09-14, under 510(k) number K842957.

Who is the listed applicant for CORITSOL PREMIX RIA KIT?

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

What is the FDA product code for CORITSOL PREMIX RIA KIT?

The FDA product code for CORITSOL PREMIX RIA KIT is CGR.

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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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