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FDA 510(k)

COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS

K-Number: K963292 · 1996-10-31

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1996-10-31
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS 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 1996-10-31 under 510(k) number K963292. The device is classified under product code CIC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS?

COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS is a medical device that received FDA 510(k) clearance on 1996-10-31. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K963292.

When did COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS receive FDA 510(k) clearance?

COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS received FDA 510(k) clearance on 1996-10-31, under 510(k) number K963292.

Who is the listed applicant for COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS?

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 INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS?

The FDA product code for COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS is CIC.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CIC)

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.

K130870HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)Hitachi Chemical Diagnostics, Inc.K083339DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)Siemens Healthcare Diagnostics, Inc.K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HHoriba AbxK053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSArkray, Inc.K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSArkray, Inc.K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTHemagen Diagnostics, 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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