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FDA 510(k)

ALT (UV) TEST

K-Number: K810355 · 1981-02-23

ApplicantBoehringer Mannheim Corp.
Decision Date1981-02-23
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALT (UV) TEST is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1981-02-23 under 510(k) number K810355. 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 ALT (UV) TEST?

ALT (UV) TEST is a medical device that received FDA 510(k) clearance on 1981-02-23. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K810355.

When did ALT (UV) TEST receive FDA 510(k) clearance?

ALT (UV) TEST received FDA 510(k) clearance on 1981-02-23, under 510(k) number K810355.

Who is the listed applicant for ALT (UV) TEST?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALT (UV) TEST?

The FDA product code for ALT (UV) TEST is CKA.

Other records listing Boehringer Mannheim Corp. as applicant

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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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