Submission Details
| 510(k) Number | K904204 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 12, 1990 |
| Decision Date | November 01, 1990 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
Cleared
Traditional
THROMBELASTOGRAPH
Nov 1990
Decision
50d
Days
Class 2
Risk
About This 510(k) Submission
K904204 is an FDA 510(k) clearance for the THROMBELASTOGRAPH, a Instrument, Coagulation, Automated (Class II — Special Controls, product code GKP), submitted by Haemoscope Corp. (Morton Grove, US). The FDA issued a Cleared decision on November 1, 1990, 50 days after receiving the submission on September 12, 1990. 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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