Coagulation Factor V Deficient Substr
FDA 510(k) K841364 · American Dade
510(k) numberK841364
Submission
- Device name
- Coagulation Factor V Deficient Substr
- Applicant
- American Dade
Walker, MI, US - Received
- April 2, 1984
- Decision date
- April 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K183440 | CRYOcheck FVIII Inhibitor KitGGP · Traditional | Precision Biologic, Inc. | 03/12/2019SE |
| K181525 | INNOVANCE Free PS AgGGP · Traditional | Siemens Healthcare Diagnostics Products GmbH | 09/07/2018SE |
| K133005 | Hemosil Von Willebrand Activity AssayGGP · Special | Instrumentation Laboratory CO | 03/13/2014SE |
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|---|---|---|
| K873051 | Stratus(R) HFSH Fluorometric Enzyme ImmunoassayCGJ · Traditional | 10/20/1987SE |
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| K873052 | Stratus(R) HLH Fluorometric Enzyme ImmunoassayCEP · Traditional | 09/14/1987SE |
| K872789 | Paramax Urine/Csf CalibratorJIX · Traditional | 09/02/1987SE |
| K872195 | Data-Fi Dimertest Latex AssayDAP · Traditional | 08/06/1987SE |
| K872196 | Aqueous Blood Gas/Electrolyte Contr Lev I,Ii & IIIJJS · Traditional | 07/31/1987SE |
| K871972 | Stratus Ige Fluorometric Enzyme ImmunoassayDGE · Traditional | 07/21/1987SE |
| K871977 | Dade Moni-Trol Chemistry Control/CalibratorJJY · Traditional | 07/09/1987SE |
| K872050 | Paramax Cholesterol ReagentLBS · Traditional | 07/07/1987SE |
| K872360 | Data-Fi Fibrin(Ogen) Degradation Prod.(Fdp)Det SetGHH · Traditional | 07/06/1987SE |
Questions and answers
When was Coagulation Factor V Deficient Substr cleared by the FDA?
Coagulation Factor V Deficient Substr (K841364) received a 510(k) decision of Substantially Equivalent on April 25, 1984, 23 days after the submission was received.
What is the product code of K841364?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.