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FDA 510(k)

DEMAND ACID PHOSPHATASE REAGENT

K-Number: K853949 · 1985-10-16

ApplicantCooper Biomedical, Inc.
Decision Date1985-10-16
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DEMAND ACID PHOSPHATASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Biomedical, Inc.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K853949. 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 DEMAND ACID PHOSPHATASE REAGENT?

DEMAND ACID PHOSPHATASE REAGENT is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Cooper Biomedical, Inc.. The 510(k) number is K853949.

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

DEMAND ACID PHOSPHATASE REAGENT received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853949.

Who is the listed applicant for DEMAND ACID PHOSPHATASE REAGENT?

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

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

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

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Other records listing Cooper Biomedical, Inc. 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.

K863868IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANTK864512IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTOK863301DEMAND TOTAL PROTEINK861926WORTHINGTON HDL PRECIPITATING REAGENT SETK854130DEMAND ETHYL ALCOHOLK852262ASSIST CLINICAL CHEMISTRY ANALYZER

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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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