K842656 is an FDA 510(k) clearance for the REPLACEMENT PARTS NOVA ELECTROLYTE ANAL. This device is classified as a Ph Rate Measurement, Carbon-dioxide (Class II - Special Controls, product code JFL).
Submitted by Shaban Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1984, 33 days after receiving the submission on July 10, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K842656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1984 |
| Decision Date | August 12, 1984 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JFL — Ph Rate Measurement, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |