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FDA 510(k)

ROCHE REAGENT FOR AST

K-Number: K843109 · 1984-11-05

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1984-11-05
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE REAGENT FOR AST is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1984-11-05 under 510(k) number K843109. 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 ROCHE REAGENT FOR AST?

ROCHE REAGENT FOR AST is a medical device that received FDA 510(k) clearance on 1984-11-05. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K843109.

When did ROCHE REAGENT FOR AST receive FDA 510(k) clearance?

ROCHE REAGENT FOR AST received FDA 510(k) clearance on 1984-11-05, under 510(k) number K843109.

Who is the listed applicant for ROCHE REAGENT FOR AST?

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

What is the FDA product code for ROCHE REAGENT FOR AST?

The FDA product code for ROCHE REAGENT FOR AST is CIT.

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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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