Submission Details
| 510(k) Number | K791658 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 1979 |
| Decision Date | October 17, 1979 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
K791658 is an FDA 510(k) clearance for the WRIGHT STAIN PACK, submitted by Bioscientific (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979, 57 days after receiving the submission on August 21, 1979. This device falls under the Hematology review panel.
| 510(k) Number | K791658 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 1979 |
| Decision Date | October 17, 1979 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | — |
| Device Class | — |