The following data is part of a premarket notification filed by Pacific Biotech, Inc. with the FDA for Directatex Strep A.
| Device ID | K861575 |
| 510k Number | K861575 |
| Device Name: | DIRECTATEX STREP A |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | PACIFIC BIOTECH, INC. 9050 CAMINO SANTA FE San Diego, CA 92121 |
| Contact | Shu-ching Cheng |
| Correspondent | Shu-ching Cheng PACIFIC BIOTECH, INC. 9050 CAMINO SANTA FE San Diego, CA 92121 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-28 |
| Decision Date | 1986-06-03 |