K833710 is an FDA 510(k) clearance for the BTC URINE LH ASSAY. This device is classified as a 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase (Class I - General Controls, product code CED).
Submitted by Btc Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984, 102 days after receiving the submission on October 20, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1520.
| 510(k) Number | K833710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1983 |
| Decision Date | January 30, 1984 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CED — 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1520 |