K803242 is an FDA 510(k) clearance for the SEROCLUSTER EIA PLATES. This device is classified as a Device, Microtiter Diluting/dispensing (Class I - General Controls, product code JTC).
Submitted by Corning Costar Corp. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981, 36 days after receiving the submission on December 23, 1980.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.2500.
| 510(k) Number | K803242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1980 |
| Decision Date | January 28, 1981 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JTC — Device, Microtiter Diluting/dispensing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2500 |