Submission Details
| 510(k) Number | K981206 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 01, 1998 |
| Decision Date | May 26, 1998 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)
May 1998
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
K981206 is an FDA 510(k) clearance for the TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS), a Instrument, Coagulation, Automated (Class II — Special Controls, product code GKP), submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on May 26, 1998, 55 days after receiving the submission on April 1, 1998. 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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