Sigma Diagnostics Auto D-Dimer, Model CRS126-A
FDA 510(k) K003267 · Sigma Diagnostics, Inc.
510(k) numberK003267
Submission
- Device name
- Sigma Diagnostics Auto D-Dimer, Model CRS126-A
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- October 18, 2000
- Decision date
- March 15, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7320
- Specialty
- Hematology
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| K160885 | HemosIL D-Dimer HSDAP · Special | Instrumentation Laboratory CO | 10/27/2016SE |
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| K141144 | Sta Liatest D-DiDAP · Traditional | Diagnostica Stago | 09/03/2014SE |
| K112818 | Vidas D-Dimer Exclusion II (DEX2)DAP · Traditional | bioMerieux, Inc. | 07/31/2012SE |
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| K093626 | Innovance D-Dimer, Model OPBP09DAP · Traditional | Siemens Healthcare Diagnostics | 11/29/2010SE |
| K090264 | Hemosil D-Dimer HS 500, ControlsDAP · Traditional | Instrumentation Laboratory CO | 02/05/2010SE |
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| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | 02/06/2002SE |
| K013549 | Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971DAP · Traditional | 12/26/2001SE |
| K013545 | Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional | 11/15/2001SE |
| K013544 | Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096DAP · Traditional | 11/15/2001SE |
| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional | 03/30/2001SE |
| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
| K003328 | Accuclot Control I, Model A4089GIZ · Traditional | 03/01/2001SE |
Questions and answers
When was Sigma Diagnostics Auto D-Dimer, Model CRS126-A cleared by the FDA?
Sigma Diagnostics Auto D-Dimer, Model CRS126-A (K003267) received a 510(k) decision of Substantially Equivalent on March 15, 2001, 148 days after the submission was received.
What is the product code of K003267?
The FDA product code is DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 864.7320.