Tintelize PAI-1 Kit
FDA 510(k) K960438 · Medical Diagnostic Technologies, Inc.
510(k) numberK960438
Submission
- Device name
- Tintelize PAI-1 Kit
- Applicant
- Medical Diagnostic Technologies, Inc.
Ventura, CA, US - Received
- January 31, 1996
- Decision date
- June 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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| K960871 | Spectrolyse Antithrombin III (Anti-Xa)JBQ · Traditional | 08/14/1996SE |
| K962489 | Chromolize Tpa Assay KitGGP · Traditional | 07/31/1996SE |
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| 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 |
| K952746 | Alkaline Phosphatase Reagent SystemCJE · Traditional | 11/27/1995SE |
Questions and answers
When was Tintelize PAI-1 Kit cleared by the FDA?
Tintelize PAI-1 Kit (K960438) received a 510(k) decision of Substantially Equivalent on June 5, 1996, 126 days after the submission was received.
What is the product code of K960438?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.