K871027 is an FDA 510(k) clearance for the PRECINORM(R) PROTEIN. This device is classified as a Gamma Globulin, Fitc, Antigen, Antiserum, Control (Class II - Special Controls, product code DAF).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 15, 1987, 60 days after receiving the submission on March 16, 1987.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K871027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 1987 |
| Decision Date | May 15, 1987 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DAF — Gamma Globulin, Fitc, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |