ROCHE REAGENT FOR C02
FDA 510(k) clearance K911838 · decided 1991-07-19
Clearance details
- K-number
- K911838
- Device name
- ROCHE REAGENT FOR C02
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-25
- Decision date
- 1991-07-19
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- CHS
- Device class
- 2
- Regulation number
- 862.1160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Montclair, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| REFLAB SYSTEM PACK LIQUID CO2 REAGENT (K926320) | Medical Analysis Systems, Inc. | 1993-02-03 |
| AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS (K860660) | Amresco, Inc. | 1986-03-14 |
| TECHNICON RA-1000 SYS CO2 (K841080) | Technicon Instruments Corp. | 1984-05-02 |
| CORNING 965 CARBON DIOXIDE ANALYZER (K811257) | Corning Medical & Scientific | 1981-05-27 |
| KODAK EKTA-CHEM CLINICAL CHEM. SLIDES (K802376) | Eastman Kodak Company | 1980-10-23 |
Recalls involving this device
No recalls on record reference this clearance.