K924021 is an FDA 510(k) clearance for the POWER SUPPLY. This device is classified as a Apparatus, Electrophoresis, For Clinical Use (Class I - General Controls, product code JJN).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on January 28, 1993, 170 days after receiving the submission on August 11, 1992.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2485.
| 510(k) Number | K924021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1992 |
| Decision Date | January 28, 1993 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JJN — Apparatus, Electrophoresis, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2485 |