Heparin Control Plasma, for Use in Aptt
FDA 510(k) K900782 · Medical Diagnostic Technologies, Inc.
510(k) numberK900782
Submission
- Device name
- Heparin Control Plasma, for Use in Aptt
- Applicant
- Medical Diagnostic Technologies, Inc.
Ventura, CA, US - Received
- February 20, 1990
- Decision date
- March 27, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGC – Control, Plasma, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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| K023312 | Control Plasma PGGC · Traditional | Dade Behring, Inc. | 11/01/2002SE |
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| K012422 | K-Assay D-Dimer ControlsGGC · Traditional | Kamiya Biomedical Co. | 08/21/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | Sigma Diagnostics, Inc. | 03/01/2001SE |
More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K062229 | CTC Workstation, Model 2200LLZ · Traditional | 09/11/2006SE |
| K972209 | Spectrolyse Heparin (Anti-Iia)KFF · Traditional | 08/12/1997SE |
| K963106 | Chromolize PAI-1 KitGGP · Traditional | 11/18/1996SE |
| K960871 | Spectrolyse Antithrombin III (Anti-Xa)JBQ · Traditional | 08/14/1996SE |
| K962489 | Chromolize Tpa Assay KitGGP · Traditional | 07/31/1996SE |
| K960438 | Tintelize PAI-1 KitGGP · Traditional | 06/05/1996SE |
| K961724 | U-Doa ControlsDIF · Traditional | 06/03/1996SE |
| K961370 | La Positive Control PlasmaGGC · Traditional | 05/24/1996SE |
| K955115 | Venom Tiem ReagentJCO · Traditional | 04/03/1996SE |
| K955738 | Bioclot Protein SGGP · Traditional | 02/29/1996SE |
Questions and answers
When was Heparin Control Plasma, for Use in Aptt cleared by the FDA?
Heparin Control Plasma, for Use in Aptt (K900782) received a 510(k) decision of Substantially Equivalent on March 27, 1990, 35 days after the submission was received.
What is the product code of K900782?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.