Abnormal Coagulation Control PLASMA-2 (ACCP-2)
FDA 510(k) K895261 · Medical Diagnostic Technologies, Inc.
510(k) numberK895261
Submission
- Device name
- Abnormal Coagulation Control PLASMA-2 (ACCP-2)
- Applicant
- Medical Diagnostic Technologies, Inc.
Ventura, CA, US - Received
- August 22, 1989
- Decision date
- October 6, 1989
- 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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| 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 Abnormal Coagulation Control PLASMA-2 (ACCP-2) cleared by the FDA?
Abnormal Coagulation Control PLASMA-2 (ACCP-2) (K895261) received a 510(k) decision of Substantially Equivalent on October 6, 1989, 45 days after the submission was received.
What is the product code of K895261?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.