The following data is part of a premarket notification filed by Sienco, Inc. with the FDA for Gbact + Kit.
| Device ID | K984141 |
| 510k Number | K984141 |
| Device Name: | GBACT + KIT |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | SIENCO, INC. 4892 VAN GORDON ST., UNIT 203 Wheatridge, CO 80033 |
| Contact | Barbara Debiase |
| Correspondent | Barbara Debiase SIENCO, INC. 4892 VAN GORDON ST., UNIT 203 Wheatridge, CO 80033 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-18 |
| Decision Date | 1999-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B55880004120 | K984141 | 000 |
| B55880004110 | K984141 | 000 |