The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Pathodx Pyr Kit.
| Device ID | K902037 |
| 510k Number | K902037 |
| Device Name: | PATHODX PYR KIT |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | B Asarch,phd |
| Correspondent | B Asarch,phd DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-04 |
| Decision Date | 1990-06-01 |