Submission Details
| 510(k) Number | K961579 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 24, 1996 |
| Decision Date | July 10, 1996 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
Jul 1996
Decision
77d
Days
Class 2
Risk
About This 510(k) Submission
K961579 is an FDA 510(k) clearance for the STA COMPACT 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 July 10, 1996, 77 days after receiving the submission on April 24, 1996. 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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