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FDA 510(k)

MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD

K-Number: K920335 · 1992-03-24

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-03-24
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1992-03-24 under 510(k) number K920335. 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 MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD?

MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD is a medical device that received FDA 510(k) clearance on 1992-03-24. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K920335.

When did MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD receive FDA 510(k) clearance?

MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD received FDA 510(k) clearance on 1992-03-24, under 510(k) number K920335.

Who is the listed applicant for MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD?

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

What is the FDA product code for MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD?

The FDA product code for MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD is CKA.

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Other records listing Heraeus Kulzer, Inc. 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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