K984141 is an FDA 510(k) clearance for the GBACT + KIT. This device is classified as a Activated Whole Blood Clotting Time (Class II - Special Controls, product code JBP).
Submitted by Sienco, Inc. (Wheatridge, US). The FDA issued a Cleared decision on May 28, 1999, 191 days after receiving the submission on November 18, 1998.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7140.
| 510(k) Number | K984141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1998 |
| Decision Date | May 28, 1999 |
| Days to Decision | 191 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JBP - Activated Whole Blood Clotting Time |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7140 |