Submission Details
| 510(k) Number | K924907 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 1992 |
| Decision Date | December 01, 1992 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
K924907 is an FDA 510(k) clearance for the FILTERMATE UNIVERSAL HARVESTER, a Device, Microtiter Diluting/dispensing (Class I — General Controls, product code JTC), submitted by Packard Instrument Co., Inc. (Downers Grove, US). The FDA issued a Cleared decision on December 1, 1992, 63 days after receiving the submission on September 29, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 866.2500.
| 510(k) Number | K924907 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 1992 |
| Decision Date | December 01, 1992 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JTC — Device, Microtiter Diluting/dispensing |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2500 |