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FDA 510(k)

OLYMPUS ACID PHOSPHATASE REAGENT

K-Number: K963640 · 1997-02-18

ApplicantOlympus America, Inc.
Decision Date1997-02-18
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS ACID PHOSPHATASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1997-02-18 under 510(k) number K963640. 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 OLYMPUS ACID PHOSPHATASE REAGENT?

OLYMPUS ACID PHOSPHATASE REAGENT is a medical device that received FDA 510(k) clearance on 1997-02-18. The listed applicant is Olympus America, Inc.. The 510(k) number is K963640.

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

OLYMPUS ACID PHOSPHATASE REAGENT received FDA 510(k) clearance on 1997-02-18, under 510(k) number K963640.

Who is the listed applicant for OLYMPUS ACID PHOSPHATASE REAGENT?

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

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

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

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Other records listing Olympus America, 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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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.K943366IL TEST ACID PHOSPHATASEInstrumentation Laboratory CO

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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