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FDA 510(k)

IL TEST ACID PHOSPHATASE

K-Number: K943366 · 1996-01-29

ApplicantInstrumentation Laboratory CO
Decision Date1996-01-29
Product CodeCKB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL TEST ACID PHOSPHATASE is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1996-01-29 under 510(k) number K943366. 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 IL TEST ACID PHOSPHATASE?

IL TEST ACID PHOSPHATASE is a medical device that received FDA 510(k) clearance on 1996-01-29. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K943366.

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

IL TEST ACID PHOSPHATASE received FDA 510(k) clearance on 1996-01-29, under 510(k) number K943366.

Who is the listed applicant for IL TEST ACID PHOSPHATASE?

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

What is the FDA product code for IL TEST ACID PHOSPHATASE?

The FDA product code for IL TEST ACID PHOSPHATASE is CKB.

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Other records listing Instrumentation Laboratory CO 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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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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