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FDA 510(k)

PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE

K-Number: K770453 · 1977-05-03

ApplicantIcn Pharmaceuticals, Inc.
Decision Date1977-05-03
Product CodeCIO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE 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 1977-05-03 under 510(k) number K770453. The device is classified under product code CIO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE?

PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE is a medical device that received FDA 510(k) clearance on 1977-05-03. The listed applicant is Icn Pharmaceuticals, Inc.. The 510(k) number is K770453.

When did PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE receive FDA 510(k) clearance?

PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE received FDA 510(k) clearance on 1977-05-03, under 510(k) number K770453.

Who is the listed applicant for PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE?

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 PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE?

The FDA product code for PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE is CIO.

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Related Devices (Code: CIO)

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.

K880177ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHATTech-Co, Inc.K860351ALKALINE PHOSPHATASE REAGENT SETSterling Diagnostics, Inc.K855192ALKALINE PHOSPHATASE REAGENT SETTechnostics Intl.K844498SANDARE ALKALINE PHOSPHATASE PROCEDURESandare Chemical Co., Inc.K844237ALKALINE PHOSPHATASE REAGENT SETLivonia Diagnostics, Inc.K841064ALKALINE PHOSPHOTASE REAGENT SETMedical Specialties, 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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