K890057 is an FDA 510(k) clearance for the SENSITITRE AUTO ID PLATE AP80. This device is classified as a Gram Negative Identification Panel (Class I - General Controls, product code LQM).
Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on June 9, 1989, 154 days after receiving the submission on January 6, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K890057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 1989 |
| Decision Date | June 09, 1989 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LQM — Gram Negative Identification Panel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |