Submission Details
| 510(k) Number | K954437 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 22, 1995 |
| Decision Date | January 30, 1996 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
THROMBELASTOGRAPH COAGULATION ANALYZER 3000S
Jan 1996
Decision
130d
Days
Class 2
Risk
About This 510(k) Submission
K954437 is an FDA 510(k) clearance for the THROMBELASTOGRAPH COAGULATION ANALYZER 3000S, a Instrument, Coagulation, Automated (Class II — Special Controls, product code GKP), submitted by Haemoscope Corp. (Skokie, US). The FDA issued a Cleared decision on January 30, 1996, 130 days after receiving the submission on September 22, 1995. 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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