510(k) K972316
- Device
- OPUS D-DIMER
- Applicant
- BEHRING DIAGNOSTICS, INC.
- 510(k) number
- K972316
- Product code
- GHH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-09-09
- Date received
- 1997-06-20
- Regulation
- 864.7320
- Classification name
- Fibrin Split Products
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ruth Forstadt
- Address
- 151 University Ave. Westwood MA US 02090 02090
FDA Registration Numbers#
- 2084025
- 3013660430
- 3013982035
- 3006198300
- 3003795116
- 1181121
- 3003985394
- 9680746
- 3014353045
- 2245451
- 9710666
- 9610529
- 9612316
- 2517506
- 8031673
- 3002637618
- 9610987
- 3029973107
- 2032900
- 9610126
- 2435505
- 2032839
Source Documents#
Other 510(k) Records For Product Code GHH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K112120 | DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET | Diazyme Laboratories | 2013-01-24 |
| K072288 | PATHFAST D-DIMER | Mitsubishi Kagaku Iatron | 2009-05-06 |
| K070453 | OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-11 |
| K062203 | TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | 2007-03-14 |
| K042890 | TRIAGE D-DIMER TEST, MODEL 98100 | Biosite Incorporated | 2004-11-29 |
| K030740 | MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | 2003-04-01 |
| K021877 | MDA D-DIMER | bioMerieux, Inc. | 2002-08-07 |
| K011143 | TINA-QUANT D-DIMER TEST SYSTEM | Roche Diagnostics Corp. | 2001-05-29 |
| K993276 | SIMPLIFY D-DIMER, MODEL DCGK1 | Agen Biomedical , Ltd. | 1999-12-14 |
| K945642 | AGEN DIMERTEST GOLD EIA | Agen Biomedical , Ltd. | 1995-10-25 |
| K921989 | FDP - SLIDEX DIRECT | Biomerieux Vitek, Inc. | 1993-11-03 |
| K920668 | MINUTEX D-DIMER LATEX TEST | Biopool AB | 1992-10-16 |
| K905643 | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY | Agen Biomedical , Ltd. | 1991-04-12 |
| K893961 | ABBOTT IMX(TM) D-DIMER | Abbott Laboratories | 1989-08-03 |
| K890422 | ABBOTT TESTPACK(TM) D-DIMER | Abbott Laboratories | 1989-03-27 |
Legacy Summary#
summary
FDA Review#
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