K791791 is an FDA 510(k) clearance for the ORTHO ANTIBODY ENHANCEMENT SOLUTION. This device is classified as a Media, Potentiating For In Vitro Diagnostic Use (Class II - Special Controls, product code KSG).
Submitted by Ortho Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 11, 1979, 30 days after receiving the submission on September 11, 1979.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9600.
| 510(k) Number | K791791 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1979 |
| Decision Date | October 11, 1979 |
| Days to Decision | 30 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 |