K121533 is an FDA 510(k) clearance for the ST AIA-PACK HOMOCYSTEINE. This device is classified as a Urinary Homocystine (nonquantitative) Test System (Class II - Special Controls, product code LPS).
Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on June 15, 2012, 22 days after receiving the submission on May 24, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1377.
| 510(k) Number | K121533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2012 |
| Decision Date | June 15, 2012 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LPS — Urinary Homocystine (nonquantitative) Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1377 |