The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Pathodx Herpes Typing.
| Device ID | K904167 |
| 510k Number | K904167 |
| Device Name: | PATHODX HERPES TYPING |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Kenneth B Asarch |
| Correspondent | Kenneth B Asarch DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-11 |
| Decision Date | 1990-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080500010 | K904167 | 000 |
| 05056080500003 | K904167 | 000 |