Submission Details
| 510(k) Number | K942117 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 03, 1994 |
| Decision Date | February 01, 1995 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
Feb 1995
Decision
274d
Days
Class 2
Risk
About This 510(k) Submission
K942117 is an FDA 510(k) clearance for the STA AUTOMATED MULTI-PARAMETRIC ANALYZER, a Instrument, Coagulation, Automated (Class II — Special Controls, product code GKP), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on February 1, 1995, 274 days after receiving the submission on May 3, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.
Device Classification
| Product Code | GKP — Instrument, Coagulation, Automated |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5400 |
Manufacturer
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