The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Group A Strep, Beta-strep.
Device ID | K884750 |
510k Number | K884750 |
Device Name: | GROUP A STREP, BETA-STREP |
Classification | Antisera, All Groups, Streptococcus Spp. |
Applicant | AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
Contact | Raymond Gould |
Correspondent | Raymond Gould AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
Product Code | GTZ |
CFR Regulation Number | 866.3740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-14 |
Decision Date | 1988-12-22 |