K830698 is an FDA 510(k) clearance for the QUANTUM II BACTERIAL IDENT. SYSTEM. This device is classified as a Kit, Identification, Enterobacteriaceae (Class I - General Controls, product code JSS).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 8, 1983, 32 days after receiving the submission on March 7, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K830698 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1983 |
| Decision Date | April 08, 1983 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSS — Kit, Identification, Enterobacteriaceae |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |