Panels › Hematology › Product code GHS · Class 2
Assay, Carboxyhemoglobin
Regulation 864.7425
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GHS
| Company | 510(k)s | Recalls |
|---|---|---|
| Corning Medical & Scientific | 1 | 0 |
| Iadec, Inc. | 1 | 0 |
| The London Co. | 1 | 0 |
| Natus Medical, Inc. | 1 | 0 |
| Radiometer America, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 11, 1998 | K974805 | CO-STAT(TM) END TIDAL BREATH ANALYZER Natus Medical, Inc. | GHS |
| Jul 9, 1991 | K910827 | ABL520 BLOOD GAS SYSTEM Radiometer America, Inc. | GHS |
| Jun 22, 1979 | K790943 | TRISEDTA-BORATE ELECTROPHORESIS FILM AGA Corning Medical & Scientific | GHS |
| Aug 3, 1977 | K771263 | RADIOMHTER OSM-2 HEMOXIMETER The London Co. | GHS |
| Mar 7, 1977 | K770209 | ECOLYZER CARBOXIMETER Iadec, Inc. | GHS |
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