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FDA 510(k)

ALKALINE PHOSPHATASE TEST SET

K-Number: K772257 · 1977-12-22

ApplicantStanbio Laboratory
Decision Date1977-12-22
Product CodeCIO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1977-12-22 under 510(k) number K772257. 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 ALKALINE PHOSPHATASE TEST SET?

ALKALINE PHOSPHATASE TEST SET is a medical device that received FDA 510(k) clearance on 1977-12-22. The listed applicant is Stanbio Laboratory. The 510(k) number is K772257.

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

ALKALINE PHOSPHATASE TEST SET received FDA 510(k) clearance on 1977-12-22, under 510(k) number K772257.

Who is the listed applicant for ALKALINE PHOSPHATASE TEST SET?

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

What is the FDA product code for ALKALINE PHOSPHATASE TEST SET?

The FDA product code for ALKALINE PHOSPHATASE TEST SET is CIO.

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Other records listing Stanbio Laboratory as applicant

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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK050283CREATININE LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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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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