The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Streptolex-stat.
| Device ID | K962296 |
| 510k Number | K962296 |
| Device Name: | STREPTOLEX-STAT |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | UNIPATH LTD. 15 OAK ST. Beverly Farms, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White UNIPATH LTD. 15 OAK ST. Beverly Farms, MA 01915 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-12 |
| Decision Date | 1996-12-16 |
| Summary: | summary |