The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Inverness Medical Testpack + Plus Strep A With Obc.
| Device ID | K051638 |
| 510k Number | K051638 |
| Device Name: | INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | UNIPATH LTD. PRIORY BUSINESS PARK Bedford, GB Mk44 3up |
| Contact | Louise Roberts |
| Correspondent | Louise Roberts UNIPATH LTD. PRIORY BUSINESS PARK Bedford, GB Mk44 3up |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-20 |
| Decision Date | 2005-12-06 |
| Summary: | summary |