K781632 is an FDA 510(k) clearance for the UROTRON. This device is classified as a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I - General Controls, product code JJQ).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978, 86 days after receiving the submission on September 25, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2300.
| 510(k) Number | K781632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1978 |
| Decision Date | December 20, 1978 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2300 |