K801089 is an FDA 510(k) clearance for the J.T. BAKER NEPHELOMETER. This device is classified as a Nephelometer, For Clinical Use (Class I - General Controls, product code JQX).
Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980, 20 days after receiving the submission on May 8, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2700.
| 510(k) Number | K801089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 1980 |
| Decision Date | May 28, 1980 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQX — Nephelometer, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2700 |