Submission Details
| 510(k) Number | K012410 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 30, 2001 |
| Decision Date | October 26, 2001 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
INFINITY HBA KIT, MODELS 537-A, 537-B
Oct 2001
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K012410 is an FDA 510(k) clearance for the INFINITY HBA KIT, MODELS 537-A, 537-B, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 26, 2001, 88 days after receiving the submission on July 30, 2001. This device falls under the Hematology 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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