ROCHE APOLIPOPROTEIN STANDARD— 510(k) K910553
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K910553 for ROCHE APOLIPOPROTEIN STANDARD, Substantially Equivalent on 1991-05-08. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code DER
- Device class
- Class 2
- Regulation
- 21 CFR 866.5580
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montclair, NJ, US
Recent devices under product code DER
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