The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Streptex Acid Extraction Kit.
| Device ID | K910797 |
| 510k Number | K910797 |
| Device Name: | STREPTEX ACID EXTRACTION KIT |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Contact | Kafader Ii |
| Correspondent | Kafader Ii WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-26 |
| Decision Date | 1991-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080501482 | K910797 | 000 |