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FDA 510(k)

GILCHEM ACID PHOSPHATASE REAGENT

K-Number: K820975 · 1982-04-26

ApplicantGilford Diagnostics
Decision Date1982-04-26
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GILCHEM ACID PHOSPHATASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1982-04-26 under 510(k) number K820975. The device is classified under product code CKB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILCHEM ACID PHOSPHATASE REAGENT?

GILCHEM ACID PHOSPHATASE REAGENT is a medical device that received FDA 510(k) clearance on 1982-04-26. The listed applicant is Gilford Diagnostics. The 510(k) number is K820975.

When did GILCHEM ACID PHOSPHATASE REAGENT receive FDA 510(k) clearance?

GILCHEM ACID PHOSPHATASE REAGENT received FDA 510(k) clearance on 1982-04-26, under 510(k) number K820975.

Who is the listed applicant for GILCHEM ACID PHOSPHATASE REAGENT?

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

What is the FDA product code for GILCHEM ACID PHOSPHATASE REAGENT?

The FDA product code for GILCHEM ACID PHOSPHATASE REAGENT is CKB.

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Other records listing Gilford Diagnostics 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.

K832094BILIRUBIN CALIBRATORS & CONTROLK831844DIRECT BILIRUBIN REAGENTK831843GILCHEM TOTAL BILIRUBIN REAGENTK823709TRIGLYCERIDE REAGENT (UV)K822739AHBDK822334BILIRUBIN CALIBRATORS

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Related Devices (Code: CKB)

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.

K053612DRI-STAT ACID PHOSPHATASE REAGENTBeckman Coulter, Inc.K023840ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650Bayer Diagnostics Corp.K991010ACPAbbott Diagnostics Mfg., Inc.K981743OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc.K974695COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)Roche Diagnostic Systems, Inc.K963640OLYMPUS ACID PHOSPHATASE REAGENTOlympus America, 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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