The following data is part of a premarket notification filed by Antibodies Inc. with the FDA for Detect-a-strep.
| Device ID | K843590 |
| 510k Number | K843590 |
| Device Name: | DETECT-A-STREP |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | ANTIBODIES INC. P.O. BOX 1560 Davis, CA 95617 |
| Contact | Jay Banovitz |
| Correspondent | Jay Banovitz ANTIBODIES INC. P.O. BOX 1560 Davis, CA 95617 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-12 |
| Decision Date | 1984-10-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DETECT-A-STREP 73480301 1339864 Dead/Cancelled |
ANTIBODIES INCORPORATED 1984-05-14 |