Submission Details
| 510(k) Number | K973696 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 1997 |
| Decision Date | November 24, 1997 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
Nov 1997
Decision
59d
Days
Class 2
Risk
About This 510(k) Submission
K973696 is an FDA 510(k) clearance for the SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on November 24, 1997, 59 days after receiving the submission on September 26, 1997. 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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