K781370 is an FDA 510(k) clearance for the MS-2 AUTOMATED URINE SCREENING SYSTEM. This device is classified as a Kit, Screening, Urine (Class I - General Controls, product code JXA).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 20, 1978, 43 days after receiving the submission on August 8, 1978.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K781370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1978 |
| Decision Date | September 20, 1978 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JXA — Kit, Screening, Urine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |