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FDA 510(k)

IL TEST PHENOBARBITAL CALIBRATORS

K-Number: K943981 · 1995-01-18

ApplicantInstrumentation Laboratory CO
Decision Date1995-01-18
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IL TEST PHENOBARBITAL CALIBRATORS 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 1995-01-18 under 510(k) number K943981. The device is classified under product code DLZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL TEST PHENOBARBITAL CALIBRATORS?

IL TEST PHENOBARBITAL CALIBRATORS is a medical device that received FDA 510(k) clearance on 1995-01-18. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K943981.

When did IL TEST PHENOBARBITAL CALIBRATORS receive FDA 510(k) clearance?

IL TEST PHENOBARBITAL CALIBRATORS received FDA 510(k) clearance on 1995-01-18, under 510(k) number K943981.

Who is the listed applicant for IL TEST PHENOBARBITAL CALIBRATORS?

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 PHENOBARBITAL CALIBRATORS?

The FDA product code for IL TEST PHENOBARBITAL CALIBRATORS is DLZ.

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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: DLZ)

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.

K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.K123271ABBOTT PHENOBARBITAL ASSAYMicrogenics Corp.K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33Abbott LaboratoriesK071644ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620Roche Diagnostics Corp.K011303RANDOX PHENOBARBITALRandox Laboratories, Ltd.K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229Syva 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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