K900887 is an FDA 510(k) clearance for the ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER. This device is classified as a Electrode, Ion-specific, Chloride (Class II - Special Controls, product code CGZ).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 15, 1990, 78 days after receiving the submission on February 26, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K900887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1990 |
| Decision Date | May 15, 1990 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGZ — Electrode, Ion-specific, Chloride |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1170 |