K964687 is an FDA 510(k) clearance for the N LATEX CRP MONO REAGENT. This device is classified as a System, Test, C-reactive Protein, Rhodamine (Class II - Special Controls, product code DCH).
Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on December 16, 1996, 90 days after receiving the submission on September 17, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K964687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1996 |
| Decision Date | December 16, 1996 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DCH — System, Test, C-reactive Protein, Rhodamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |