K022829 is an FDA 510(k) clearance for the INSTANT-VIEW LH OVULATION PREDICTING TEST. This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I - General Controls, product code CEP).
Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on November 5, 2002, 71 days after receiving the submission on August 26, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1485.
| 510(k) Number | K022829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2002 |
| Decision Date | November 05, 2002 |
| Days to Decision | 71 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CEP — Radioimmunoassay, Luteinizing Hormone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1485 |