The following data is part of a premarket notification filed by Btc Diagnostics, Inc. with the FDA for Btc Urine Lh Assay.
| Device ID | K833710 |
| 510k Number | K833710 |
| Device Name: | BTC URINE LH ASSAY |
| Classification | 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase |
| Applicant | BTC DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CED |
| CFR Regulation Number | 862.1520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-20 |
| Decision Date | 1984-01-30 |