ROCHE ISOMUNE- CK— 510(k) K903025
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K903025 for ROCHE ISOMUNE- CK, Substantially Equivalent on 1990-08-09. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code JHS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montclair, NJ, US
Recent devices under product code JHS
view allMore clearances from Roche Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.