Submission Details
| 510(k) Number | K982209 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 23, 1998 |
| Decision Date | October 15, 1998 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
Oct 1998
Decision
114d
Days
Class 2
Risk
About This 510(k) Submission
K982209 is an FDA 510(k) clearance for the ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589, a Test, Thrombin Time (Class II — Special Controls, product code GJA), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 15, 1998, 114 days after receiving the submission on June 23, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7875.
Device Classification
| Product Code | GJA — Test, Thrombin Time |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7875 |
Manufacturer
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