Document CK Isoenzymes Control
FDA 510(k) K915792 · Casco Standards
510(k) numberK915792
Submission
- Device name
- Document CK Isoenzymes Control
- Applicant
- Casco Standards
Yarmouth, ME, US - Received
- December 24, 1991
- Decision date
- February 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CDP – Radioimmunoassay, Total Triiodothyronine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1710
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K983439 | Abbott Architect Free T3CDP · Traditional | Abbott Laboratories | 11/20/1998SE |
| K983434 | Abbott Architect Total T3CDP · Traditional | Abbott Laboratories | 11/20/1998SE |
| K974027 | Auraflex FT3 150 Test Pack, Auraflex FT3 Calibrator PackCDP · Traditional | Alfa Biotech (Uk) , Ltd. | 02/02/1998SE |
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| K973966 | Access Total T3 Reagents on the Access Immunoassay AnalyzerCDP · Traditional | Beckman Instruments, Inc. | 10/31/1997SE |
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| K960244 | Document TDM Ultra Assayed ControlDIF · Traditional | 03/22/1996SE |
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Questions and answers
When was Document CK Isoenzymes Control cleared by the FDA?
Document CK Isoenzymes Control (K915792) received a 510(k) decision of Substantially Equivalent on February 6, 1992, 44 days after the submission was received.
What is the product code of K915792?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.