K102638 is an FDA 510(k) clearance for the DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on November 30, 2010, 77 days after receiving the submission on September 14, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K102638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2010 |
| Decision Date | November 30, 2010 |
| Days to Decision | 77 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |