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 |