K761234 is an FDA 510(k) clearance for the BEHRING LASER NEPHELOMETER. This device is classified as a Nephelometer (Class I - General Controls, product code JZW).
Submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on June 7, 1990.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4540.
| 510(k) Number | K761234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1990 |
| Decision Date | June 07, 1990 |
| Days to Decision | — |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JZW — Nephelometer |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.4540 |