The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Status First Strep A.
| Device ID | K040708 |
| 510k Number | K040708 |
| Device Name: | STATUS FIRST STREP A |
| 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 | 2004-03-18 |
| Decision Date | 2004-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855574005438 | K040708 | 000 |
| 00855574005421 | K040708 | 000 |