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FDA 510(k)

CENTRIFICHEM ALP/ALKALINE PHOSPHATASE

K-Number: K800131 · 1980-02-11

ApplicantUnion Carbide Corp.
Decision Date1980-02-11
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIFICHEM ALP/ALKALINE PHOSPHATASE 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 1980-02-11 under 510(k) number K800131. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIFICHEM ALP/ALKALINE PHOSPHATASE?

CENTRIFICHEM ALP/ALKALINE PHOSPHATASE is a medical device that received FDA 510(k) clearance on 1980-02-11. The listed applicant is Union Carbide Corp.. The 510(k) number is K800131.

When did CENTRIFICHEM ALP/ALKALINE PHOSPHATASE receive FDA 510(k) clearance?

CENTRIFICHEM ALP/ALKALINE PHOSPHATASE received FDA 510(k) clearance on 1980-02-11, under 510(k) number K800131.

Who is the listed applicant for CENTRIFICHEM ALP/ALKALINE PHOSPHATASE?

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 ALP/ALKALINE PHOSPHATASE?

The FDA product code for CENTRIFICHEM ALP/ALKALINE PHOSPHATASE is CJE.

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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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