The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Patho Dx Strep D.
| Device ID | K902038 |
| 510k Number | K902038 |
| Device Name: | PATHO DX STREP D |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| 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 | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-04 |
| Decision Date | 1990-05-21 |