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 |