K940243 is an FDA 510(k) clearance for the VENTANA EMA PRIMARY ANDIBODY. This device is classified as a D/km-1, Antigen, Antiserum, Control (Class I - General Controls, product code DHF).
Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on September 7, 1994, 231 days after receiving the submission on January 19, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5065.
| 510(k) Number | K940243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1994 |
| Decision Date | September 07, 1994 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DHF — D/km-1, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5065 |