Access Total T3 Assay (Modification)
FDA 510(k) K955435 · Bio-Rad Laboratories, Inc.
510(k) numberK955435
Submission
- Device name
- Access Total T3 Assay (Modification)
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- October 2, 1995
- Decision date
- January 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K983439 | Abbott Architect Free T3CDP · Traditional | Abbott Laboratories | 11/20/1998SE |
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| K974634 | Immulite Free T3CDP · Traditional | Diagnostic Products Corp. | 01/02/1998SE |
| K973966 | Access Total T3 Reagents on the Access Immunoassay AnalyzerCDP · Traditional | Beckman Instruments, Inc. | 10/31/1997SE |
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Questions and answers
When was Access Total T3 Assay (Modification) cleared by the FDA?
Access Total T3 Assay (Modification) (K955435) received a 510(k) decision of Substantially Equivalent on January 24, 1996, 114 days after the submission was received.
What is the product code of K955435?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.