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FDA 510(k)

COBAS READY STAT PROFILE REAGENT STRIP

K-Number: K896234 · 1990-02-16

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

Device Summary

COBAS READY STAT PROFILE 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 K896234. 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 COBAS READY STAT PROFILE REAGENT STRIP?

COBAS READY STAT PROFILE 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 K896234.

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

COBAS READY STAT PROFILE REAGENT STRIP received FDA 510(k) clearance on 1990-02-16, under 510(k) number K896234.

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

The FDA product code for COBAS READY STAT PROFILE REAGENT STRIP is CKA.

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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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