Accuclot Control I, Model A4089
FDA 510(k) K003328 · Sigma Diagnostics, Inc.
510(k) numberK003328
Submission
- Device name
- Accuclot Control I, Model A4089
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- October 24, 2000
- Decision date
- March 1, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GIZ – Plasma, Control, Normal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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|---|---|---|---|
| K060968 | Stasis - I, II and III; Serathan - a, B; Intrin - Ea, Si Calcium Chloride 0.02M…GIZ · Traditional | Wortham Laboratories, Inc. | 05/15/2007SE |
| K042941 | Dade Behring Heparin Calibrator and ControlsGIZ · Traditional | Dade Behring, Inc. | 12/02/2004SE |
| K023309 | Control Plasma NGIZ · Traditional | Dade Behring, Inc. | 11/01/2002SE |
| K013708 | Reference Check, Catalog NUMBER-RCN-10GIZ · Traditional | Precision Biologic | 12/10/2001SE |
| K001256 | Control Plasma NGIZ · Traditional | Dade Behring, Inc. | 05/24/2000SE |
| K984129 | Coagulation Control Level 1 (Normal)GIZ · Traditional | Pacific Hemostasis | 12/01/1998SE |
| K973274 | Accucolor High Calibrator (A3089)GIZ · Traditional | Sigma Diagnostics, Inc. | 10/31/1997SE |
| K961814 | Thrombolytic Assessment System Prothrombin Time Test ControlsGIZ · Traditional | Cardiovascular Diagnostics, Inc. | 08/13/1996SE |
| K941737 | Specialty Assayed CONTROL-1GIZ · Traditional | Helena Laboratories | 10/07/1994SE |
| K935254 | Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control PlasmaGIZ · Traditional | American Diagnostica, Inc. | 09/19/1994SE |
More from American Diagnostica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021162 | Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-Eu, Amax Destiny…JPA · Traditional | 08/30/2002SE |
| 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 |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
Questions and answers
When was Accuclot Control I, Model A4089 cleared by the FDA?
Accuclot Control I, Model A4089 (K003328) received a 510(k) decision of Substantially Equivalent on March 1, 2001, 128 days after the submission was received.
What is the product code of K003328?
The FDA product code is GIZ – Plasma, Control, Normal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.