K973389 is an FDA 510(k) clearance for the CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING. This device is classified as a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II - Special Controls, product code DEM).
Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on October 3, 1997, 85 days after receiving the submission on July 10, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5130.
| 510(k) Number | K973389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1997 |
| Decision Date | October 03, 1997 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5130 |