ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)— 510(k) K972214
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K972214 for ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN), Substantially Equivalent on 1997-06-24. Applicant: Roche Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
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