The following data is part of a premarket notification filed by Blackhawk Biosystems, Inc. with the FDA for Chlamydiatrol Ag.
| Device ID | K972129 |
| 510k Number | K972129 |
| Device Name: | CHLAMYDIATROL AG |
| Classification | Kit, Direct Antigen, Positive Control |
| Applicant | BLACKHAWK BIOSYSTEMS, INC. 12945 ALCOSTA BLVD. San Ramon, CA 94583 |
| Contact | Carole Polito |
| Correspondent | Carole Polito BLACKHAWK BIOSYSTEMS, INC. 12945 ALCOSTA BLVD. San Ramon, CA 94583 |
| Product Code | MJZ |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-06 |
| Decision Date | 1997-08-12 |
| Summary: | summary |