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FDA 510(k)

COBAS READY PROFILE 1 REAGENT STRIP

K-Number: K896229 · 1990-02-16

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-02-16
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS READY PROFILE 1 REAGENT STRIP 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 1990-02-16 under 510(k) number K896229. 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 COBAS READY PROFILE 1 REAGENT STRIP?

COBAS READY PROFILE 1 REAGENT STRIP is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K896229.

When did COBAS READY PROFILE 1 REAGENT STRIP receive FDA 510(k) clearance?

COBAS READY PROFILE 1 REAGENT STRIP received FDA 510(k) clearance on 1990-02-16, under 510(k) number K896229.

Who is the listed applicant for COBAS READY PROFILE 1 REAGENT STRIP?

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 COBAS READY PROFILE 1 REAGENT STRIP?

The FDA product code for COBAS READY PROFILE 1 REAGENT STRIP 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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