The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Reveal Colour Strep A Zl16.
| Device ID | K864206 |
| 510k Number | K864206 |
| Device Name: | REVEAL COLOUR STREP A ZL16 |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Contact | Moody, Ph.d. |
| Correspondent | Moody, Ph.d. 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 | 1986-10-27 |
| Decision Date | 1987-01-13 |