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FDA 510(k)

ALKALINE PHOSPHATASE ENZYMATIC

K-Number: K770316 · 1977-03-30

ApplicantIcn Pharmaceuticals, Inc.
Decision Date1977-03-30
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE ENZYMATIC is the device name listed in this FDA 510(k) record. The listed applicant is Icn Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1977-03-30 under 510(k) number K770316. 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 ALKALINE PHOSPHATASE ENZYMATIC?

ALKALINE PHOSPHATASE ENZYMATIC is a medical device that received FDA 510(k) clearance on 1977-03-30. The listed applicant is Icn Pharmaceuticals, Inc.. The 510(k) number is K770316.

When did ALKALINE PHOSPHATASE ENZYMATIC receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE ENZYMATIC received FDA 510(k) clearance on 1977-03-30, under 510(k) number K770316.

Who is the listed applicant for ALKALINE PHOSPHATASE ENZYMATIC?

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

What is the FDA product code for ALKALINE PHOSPHATASE ENZYMATIC?

The FDA product code for ALKALINE PHOSPHATASE ENZYMATIC is CJE.

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Related Devices (Code: 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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