K840977 is an FDA 510(k) clearance for the LIQUID CHROMATOGRAPHIC DETECTOR LC-95. This device is classified as a Chromatography (liquid, Gel), Clinical Use (Class I - General Controls, product code KZR).
Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1984, 44 days after receiving the submission on March 6, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2260.
| 510(k) Number | K840977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1984 |
| Decision Date | April 19, 1984 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KZR — Chromatography (liquid, Gel), Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2260 |