K964843 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT. This device is classified as a Factor B, Antigen, Antiserum, Control (Class II - Special Controls, product code JZH).
Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 6, 1997, 93 days after receiving the submission on December 3, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5320.
| 510(k) Number | K964843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1996 |
| Decision Date | March 06, 1997 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JZH — Factor B, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5320 |