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FDA 510(k)

CENTRIFICHEM 200MG/DL CHOL. CAL. STD.

K-Number: K770127 · 1977-01-31

ApplicantUnion Carbide Corp.
Decision Date1977-01-31
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIFICHEM 200MG/DL CHOL. CAL. STD. is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1977-01-31 under 510(k) number K770127. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIFICHEM 200MG/DL CHOL. CAL. STD.?

CENTRIFICHEM 200MG/DL CHOL. CAL. STD. is a medical device that received FDA 510(k) clearance on 1977-01-31. The listed applicant is Union Carbide Corp.. The 510(k) number is K770127.

When did CENTRIFICHEM 200MG/DL CHOL. CAL. STD. receive FDA 510(k) clearance?

CENTRIFICHEM 200MG/DL CHOL. CAL. STD. received FDA 510(k) clearance on 1977-01-31, under 510(k) number K770127.

Who is the listed applicant for CENTRIFICHEM 200MG/DL CHOL. CAL. STD.?

The FDA 510(k) record lists Union Carbide Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTRIFICHEM 200MG/DL CHOL. CAL. STD.?

The FDA product code for CENTRIFICHEM 200MG/DL CHOL. CAL. STD. is JIT.

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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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