Submission Details
| 510(k) Number | K920759 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 1992 |
| Decision Date | April 29, 1992 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
CRITSPIN MICRO-HEMATOCRIT
Apr 1992
Decision
70d
Days
Class 2
Risk
About This 510(k) Submission
K920759 is an FDA 510(k) clearance for the CRITSPIN MICRO-HEMATOCRIT, a Centrifuge, Hematocrit (Class II — Special Controls, product code GKG), submitted by Stat-Spin Technologies (Norwood, US). The FDA issued a Cleared decision on April 29, 1992, 70 days after receiving the submission on February 19, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.
Device Classification
| Product Code | GKG — Centrifuge, Hematocrit |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.6400 |
Manufacturer
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