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FDA 510(k), K994349, COAGUCHEK S SYSTEM, MODEL 2138280
FDA 510(k), K994349, COAGUCHEK S SYSTEM, MODEL 2138280
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510(K) Number: K994349
Device Name: COAGUCHEK S SYSTEM, MODEL 2138280
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 12/23/1999
Decision Date: 09/06/2000
Regulation Medical Specialty: Hematology
Device Name: COAGUCHEK S SYSTEM, MODEL 2138280
Manufacturer: ROCHE DIAGNOSTICS CORP.
Device Classification Name: system, multipurpose for in vitro coagulation studies
Regulation Number: 864.5425
Classification Product Code: JPA
Date Received: 12/23/1999
Decision Date: 09/06/2000
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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