Submission Details
| 510(k) Number | K854121 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 09, 1985 |
| Decision Date | October 31, 1985 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
Cleared
Traditional
MICRO-MAT SYSTEM
Oct 1985
Decision
22d
Days
Class 1
Risk
About This 510(k) Submission
K854121 is an FDA 510(k) clearance for the MICRO-MAT SYSTEM, a Spinner, Slide, Automated (Class I — General Controls, product code GKJ), submitted by Prevo Micro-Mat System (Highland, US). The FDA issued a Cleared decision on October 31, 1985, 22 days after receiving the submission on October 9, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5850.
Device Classification
| Product Code | GKJ — Spinner, Slide, Automated |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.5850 |
Manufacturer
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