K902220 is an FDA 510(k) clearance for the PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL. This device is classified as a Whole Human Serum, Antigen, Antiserum, Control (Class I - General Controls, product code DGR).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 5, 1990, 111 days after receiving the submission on May 17, 1990.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5700.
| 510(k) Number | K902220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 1990 |
| Decision Date | September 05, 1990 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DGR — Whole Human Serum, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5700 |