510(k) K042919
- Device
- FIBROTEK FIB
- Applicant
- R2 DIAGNOSTICS, INC.
- 510(k) number
- K042919
- Product code
- GIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-11-29
- Date received
- 2004-10-22
- Regulation
- 864.7340
- Classification name
- Test, Fibrinogen
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PEGGY S CARTER
- Address
- 412 S. Lafayette Blvd. South Bend IN US 46601 46601
FDA Registration Numbers#
- 2084025
- 2032900
- 3037000637
- 2431530
- 1000403749
- 1835316
- 1181121
Source Documents#
Other 510(k) Records For Product Code GIS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set | Diazyme Laboratories | 2016-01-31 |
| K993482 | K-ASSAY FIBRINOGEN | Kamiya Biomedical Co. | 1999-12-06 |
| K963902 | QUANTITATIVE FIBRINOGEN ASSAY | Ortho Diagnostic Systems, Inc. | 1996-11-29 |
| K941001 | ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT | Diagnostic Specialties | 1994-08-30 |
| K925494 | BIOMERIEUX HEMOLAB FIBRINOMAT | Biomerieux Vitek, Inc. | 1993-05-18 |
| K923921 | IL TEST PT FIBRINOGEN HS | Instrumentation Laboratory CO | 1992-10-26 |
| K913061 | FIBRINOGEN DETERMINATION KIT | Sigma Diagnostics, Inc. | 1991-10-09 |
| K910636 | ABS CADKIT | Panbio, Inc. | 1991-04-29 |
| K903874 | FIBRINOTEST(TM) - FIBRINOGEN ASSAY | Haemachem, Inc. | 1991-02-14 |
| K881685 | FIBRINOGENTEST-O | Diatech, Inc. | 1988-08-09 |
| K881150 | KINETIC FIBRINOGEN ASSAY | Bio/Data Corp. | 1988-03-28 |
| K781880 | ASSAY KIT, THROMBO-SCREEN | Pacific Hemostasis | 1978-12-04 |
Legacy Summary#
summary
FDA Review#
Decision Summary