Submission Details
| 510(k) Number | K063209 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 23, 2006 |
| Decision Date | March 21, 2007 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
Mar 2007
Decision
149d
Days
Class 2
Risk
About This 510(k) Submission
K063209 is an FDA 510(k) clearance for the HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on March 21, 2007, 149 days after receiving the submission on October 23, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.
Device Classification
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7470 |
Manufacturer
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