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 |