The following data is part of a premarket notification filed by Bcsi Laboratories, Inc. with the FDA for Breast Thermal Activity Indicator.
| Device ID | K832989 |
| 510k Number | K832989 |
| Device Name: | BREAST THERMAL ACTIVITY INDICATOR |
| Classification | System, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use) |
| Applicant | BCSI LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYA |
| CFR Regulation Number | 884.2982 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-01 |
| Decision Date | 1984-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B737WC0010 | K832989 | 000 |