K800943 is an FDA 510(k) clearance for the PENTEX BOVINE ALBUMIN 30% SOLUTION. This device is classified as a Media, Potentiating For In Vitro Diagnostic Use (Class II - Special Controls, product code KSG).
Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1980, 16 days after receiving the submission on April 22, 1980.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9600.
| 510(k) Number | K800943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1980 |
| Decision Date | May 08, 1980 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSG — Media, Potentiating For In Vitro Diagnostic Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9600 |