510(k) K022976
- Device
- STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K022976
- Product code
- DAP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-16
- Date received
- 2002-09-06
- Regulation
- 864.7320
- Classification name
- Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD M VAUGHT
- Address
- Glasgow Business Community Bldg. 500, Ms 514 P.O.Box 6101 Newark DE US 19714 19714
FDA Registration Numbers#
- 2084025
- 3013660430
- 3013982035
- 3006198300
- 2246703
- 3005360469
- 3003030793
- 1181121
- 3003985394
- 9610806
- 9615037
- 3005174594
- 2245451
- 3008386529
- 9710666
- 1217183
- 2020726
- 1219738
- 2517506
- 3002637618
- 9610746
- 3003691680
- 3037000637
- 2032900
- 9610126
- 2029372
- 8020790
- 3003750284
Source Documents#
Other 510(k) Records For Product Code DAP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172903 | HemosIL D-Dimer HS 500 | Instrumentation Laboratory CO | 2017-11-22 |
| K162227 | STA® - Liatest® D-Di | Diagnostica Stago | 2016-12-10 |
| K160885 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | 2016-10-27 |
| K151534 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | 2015-07-06 |
| K141144 | STA LIATEST D-DI | Diagnostica Stago | 2014-09-03 |
| K112818 | VIDAS D-DIMER EXCLUSION II (DEX2) | bioMerieux, Inc. | 2012-07-31 |
| K110303 | STRATUS CS ACUTE CARE D-DIMER | Siemens Healthcare Diagnostics | 2011-05-16 |
| K093626 | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | 2010-11-29 |
| K090264 | HEMOSIL D-DIMER HS 500, CONTROLS | Instrumentation Laboratory CO | 2010-02-05 |
| K091916 | INNOVANCE D-DIMER, MODEL OPBP09 | Siemens Healthcare Diagnostics | 2009-10-29 |
| K081732 | INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS | Siemens Healthcare Diagnostics | 2008-10-24 |
| K073042 | HEMOSIL D-DIMER | Instrumentation Laboratory | 2008-07-31 |
| K080069 | DIMERTEST | American Diagnostica, Inc. | 2008-02-13 |
| K070927 | HEMOSIL D-DIMER HS | Instrumentation Laboratory CO | 2007-09-17 |
| K063356 | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK | Dade Behring, Inc. | 2007-03-23 |
Legacy Summary#
summary
FDA Review#
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