The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Patho Dx Latex Agglutination Strep A.
| Device ID | K842383 |
| 510k Number | K842383 |
| Device Name: | PATHO DX LATEX AGGLUTINATION STREP A |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-18 |
| Decision Date | 1984-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080501345 | K842383 | 000 |
| 05056080501338 | K842383 | 000 |
| 05056080501321 | K842383 | 000 |
| 05056080501314 | K842383 | 000 |
| 05056080501307 | K842383 | 000 |