The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biosign Strep A - Direct Strep A Antigen Test.
| Device ID | K971349 |
| 510k Number | K971349 |
| Device Name: | BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1997-07-07 |