K983510 is an FDA 510(k) clearance for the CHEMSTRIP 101 URINE ANALYZER. This device is classified as a Automated Urinalysis System (Class I - General Controls, product code KQO).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 27, 1998, 20 days after receiving the submission on October 7, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2900.
| 510(k) Number | K983510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1998 |
| Decision Date | October 27, 1998 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KQO — Automated Urinalysis System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2900 |