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FDA 510(k)

ALKALINE PHOSPHATASE ISOENZY. SUB. SET

K-Number: K771620 · 1977-09-15

ApplicantPfizer, Inc.
Decision Date1977-09-15
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE ISOENZY. SUB. SET is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 1977-09-15 under 510(k) number K771620. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKALINE PHOSPHATASE ISOENZY. SUB. SET?

ALKALINE PHOSPHATASE ISOENZY. SUB. SET is a medical device that received FDA 510(k) clearance on 1977-09-15. The listed applicant is Pfizer, Inc.. The 510(k) number is K771620.

When did ALKALINE PHOSPHATASE ISOENZY. SUB. SET receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE ISOENZY. SUB. SET received FDA 510(k) clearance on 1977-09-15, under 510(k) number K771620.

Who is the listed applicant for ALKALINE PHOSPHATASE ISOENZY. SUB. SET?

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

What is the FDA product code for ALKALINE PHOSPHATASE ISOENZY. SUB. SET?

The FDA product code for ALKALINE PHOSPHATASE ISOENZY. SUB. SET is CIN.

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Related Devices (Code: CIN)

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.

K232904Access OstaseBeckman CoulterK200475IDS-iSYS Ostase BAPImmunodiagnostic Systems , Ltd.K043125ORION DIAGNOSTICA UNIQ PINP RIAOrion Diagnostica, OYK020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346Helena LaboratoriesK011113HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)SebiaK994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman Coulter, 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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