K833804 is an FDA 510(k) clearance for the SHABAN 9865 IL#78637 JUNCTION BLOC. This device is classified as a Analyzer, Chemistry, Micro, For Clinical Use (Class I - General Controls, product code JJF).
Submitted by Shaban Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984, 73 days after receiving the submission on November 1, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2170.
| 510(k) Number | K833804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1983 |
| Decision Date | January 13, 1984 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJF — Analyzer, Chemistry, Micro, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2170 |