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 |