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FDA 510(k)

STANBIO PROSTATIC ACID PHOSPHATASE TEST

K-Number: K800693 · 1980-04-16

ApplicantStanbio Laboratory
Decision Date1980-04-16
Product CodeCKE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STANBIO PROSTATIC ACID PHOSPHATASE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1980-04-16 under 510(k) number K800693. The device is classified under product code CKE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANBIO PROSTATIC ACID PHOSPHATASE TEST?

STANBIO PROSTATIC ACID PHOSPHATASE TEST is a medical device that received FDA 510(k) clearance on 1980-04-16. The listed applicant is Stanbio Laboratory. The 510(k) number is K800693.

When did STANBIO PROSTATIC ACID PHOSPHATASE TEST receive FDA 510(k) clearance?

STANBIO PROSTATIC ACID PHOSPHATASE TEST received FDA 510(k) clearance on 1980-04-16, under 510(k) number K800693.

Who is the listed applicant for STANBIO PROSTATIC ACID PHOSPHATASE TEST?

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 STANBIO PROSTATIC ACID PHOSPHATASE TEST?

The FDA product code for STANBIO PROSTATIC ACID PHOSPHATASE TEST is CKE.

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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: CKE)

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.

K914167CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASEEastman Kodak CompanyK915705ACID PHOSPHATASE REAGENT SETTech Intl. Co.K873726ACID PHOSPHATASE TESTKing Diagnostics, Inc.K864230DIMENSION (TM) CLINICAL CHEMISTRY SYSTEME.I. Dupont DE Nemours & Co., Inc.K860476ACID PHOSPHATASE REAGENT SETSterling Diagnostics, Inc.K843380ACID PHOSPHATASE ASSAY KITDiagnostic Chemicals, Ltd. (Usa)

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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