K954299 is an FDA 510(k) clearance for the BUHLMANN ANGIOSTENSIN II RIA. This device is classified as a Radioimmunoassay, Angiotensin I And Renin (Class II - Special Controls, product code CIB).
Submitted by Buhlmann Laboratories AG (Windham, US). The FDA issued a Cleared decision on October 19, 1995, 35 days after receiving the submission on September 14, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1085.
| 510(k) Number | K954299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1995 |
| Decision Date | October 19, 1995 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CIB - Radioimmunoassay, Angiotensin I And Renin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1085 |