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FDA 510(k)

MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD

K-Number: K920336 · 1992-03-04

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-03-04
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MILES ASPARTATE 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 1992-03-04 under 510(k) number K920336. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD?

MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD is a medical device that received FDA 510(k) clearance on 1992-03-04. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K920336.

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

MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD received FDA 510(k) clearance on 1992-03-04, under 510(k) number K920336.

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

The FDA product code for MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD is CIT.

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Other records listing Heraeus Kulzer, Inc. as applicant

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K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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Related Devices (Code: CIT)

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.

K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-Seppim S.A.S.K080485ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FSDiasys Diagnostics Systems GmbHK071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott LaboratoriesK071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OYK071211COBAS C 111 ANALYZERRoche DiagnosticsK060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx

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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