The following data is part of a premarket notification filed by Btc Corp. with the FDA for Btc Chlamydia Direct Specimen Test & Control Slide.
| Device ID | K883776 |
| 510k Number | K883776 |
| Device Name: | BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE |
| Classification | Antisera, Fluorescent, Chlamydia Spp. |
| Applicant | BTC CORP. 324 CAMPUS LANE, SUITE T Suisun, CA 94585 |
| Contact | June Pohlman |
| Correspondent | June Pohlman BTC CORP. 324 CAMPUS LANE, SUITE T Suisun, CA 94585 |
| Product Code | LKI |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-06 |
| Decision Date | 1989-02-03 |