K801892 is an FDA 510(k) clearance for the KLINAR REAGENT PAK, #36010. This device is classified as a Flame Photometry, Sodium (Class II - Special Controls, product code JGT).
Submitted by Hi Chem, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980, 76 days after receiving the submission on August 8, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K801892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1980 |
| Decision Date | October 23, 1980 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGT — Flame Photometry, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |