COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C— 510(k) K851032
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K851032 for COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C, Substantially Equivalent on 1985-04-03. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code KXT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Belleville, NJ, US
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More clearances from Roche Diagnostic Systems, Inc.
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