Dade Thromboplastin C Plus
FDA 510(k) K013155 · Dade Behring, Inc.
510(k) numberK013155
Submission
- Device name
- Dade Thromboplastin C Plus
- Applicant
- Dade Behring, Inc.
Miami, FL, US - Received
- September 21, 2001
- Decision date
- January 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GJS – Test, Time, Prothrombin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7750
- Specialty
- Hematology
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| K213426 | HemosIL ReadiPlasTinGJS · Traditional | Instrumentation Laboratory CO | 08/16/2022SE |
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Questions and answers
When was Dade Thromboplastin C Plus cleared by the FDA?
Dade Thromboplastin C Plus (K013155) received a 510(k) decision of Substantially Equivalent on January 18, 2002, 119 days after the submission was received.
What is the product code of K013155?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.