Submission Details
| 510(k) Number | K910255 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 22, 1991 |
| Decision Date | April 03, 1991 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
Cleared
Traditional
FLOW CYTOMETRY FITC/PE COMPENSATION KIT
Apr 1991
Decision
71d
Days
Class 2
Risk
About This 510(k) Submission
K910255 is an FDA 510(k) clearance for the FLOW CYTOMETRY FITC/PE COMPENSATION KIT, a Calibrator, Surrogate (Class II — Special Controls, product code JIW), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 3, 1991, 71 days after receiving the submission on January 22, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIW — Calibrator, Surrogate |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
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