The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Coat-a-count Direct Androstenedione.
| Device ID | K954755 |
| 510k Number | K954755 |
| Device Name: | COAT-A-COUNT DIRECT ANDROSTENEDIONE |
| Classification | Radioimmunoassay, Androstenedione |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine |
| Correspondent | Edward M Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | CIZ |
| CFR Regulation Number | 862.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-16 |
| Decision Date | 1995-11-29 |