K811805 is an FDA 510(k) clearance for the TRYPIN (125I) RIA KIT. This device is classified as a N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (Class I - General Controls, product code JNO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 31, 1981, 68 days after receiving the submission on June 24, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1725.
| 510(k) Number | K811805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1981 |
| Decision Date | August 31, 1981 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JNO — N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1725 |