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FDA 510(k)

IL TEST ALT, PN 35311

K-Number: K923623 · 1992-09-17

ApplicantInstrumentation Laboratory CO
Decision Date1992-09-17
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL TEST ALT, PN 35311 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 1992-09-17 under 510(k) number K923623. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL TEST ALT, PN 35311?

IL TEST ALT, PN 35311 is a medical device that received FDA 510(k) clearance on 1992-09-17. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K923623.

When did IL TEST ALT, PN 35311 receive FDA 510(k) clearance?

IL TEST ALT, PN 35311 received FDA 510(k) clearance on 1992-09-17, under 510(k) number K923623.

Who is the listed applicant for IL TEST ALT, PN 35311?

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 ALT, PN 35311?

The FDA product code for IL TEST ALT, PN 35311 is CKA.

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Related Devices (Code: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace 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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