K873407 is an FDA 510(k) clearance for the RRT SYSTEM LASER REFLECTOMETER ANALYZER. This device is classified as a Nephelometer (Class I - General Controls, product code JZW).
Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on September 23, 1987, 29 days after receiving the submission on August 25, 1987.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4540.
| 510(k) Number | K873407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1987 |
| Decision Date | September 23, 1987 |
| Days to Decision | 29 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 |