K892223 is an FDA 510(k) clearance for the BEHRING NEPHELOMETER 100. This device is classified as a Nephelometer (Class I - General Controls, product code JZW).
Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on May 4, 1989, 31 days after receiving the submission on April 3, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4540.
| 510(k) Number | K892223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1989 |
| Decision Date | May 04, 1989 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JZW — Nephelometer |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.4540 |