510(k) K911838
- Device
- ROCHE REAGENT FOR C02
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K911838
- Product code
- CHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-07-19
- Date received
- 1991-04-25
- Regulation
- 862.1160
- Classification name
- Coulometric Method, Carbon-dioxide
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL L KRIEGER
- Address
- One Sunset Ave. Montclair NJ US 07042 07042
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CHS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K926320 | REFLAB SYSTEM PACK LIQUID CO2 REAGENT | Medical Analysis Systems, Inc. | 1993-02-03 |
| K860660 | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | Amresco, Inc. | 1986-03-14 |
| K841080 | TECHNICON RA-1000 SYS CO2 | Technicon Instruments Corp. | 1984-05-02 |
| K811257 | CORNING 965 CARBON DIOXIDE ANALYZER | Corning Medical & Scientific | 1981-05-27 |
| K802376 | KODAK EKTA-CHEM CLINICAL CHEM. SLIDES | Eastman Kodak Company | 1980-10-23 |
Legacy Summary#
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FDA Review#
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