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FDA 510(k), K951595, ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
FDA 510(k), K951595, ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
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510(K) Number: K951595
Device Name: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
Manufacturer: CAROL L KRIEGER
Device Classification Name: Alkaline Picrate, Colorimetry, Creatinine
Regulation Number: CGX
Classification Product Code: 04/06/1995
Date Received: 09/08/1995
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
Manufacturer: CAROL L KRIEGER
Device Classification Name: Alkaline Picrate, Colorimetry, Creatinine
Regulation Number: CGX
Classification Product Code: 04/06/1995
Date Received: 09/08/1995
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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