Simultrac Free T4(57CO)/TSH[125I] Radioimmunoassay
FDA 510(k) K853628 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK853628
Submission
- Device name
- Simultrac Free T4(57CO)/TSH[125I] Radioimmunoassay
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Paramus, NJ, US - Received
- August 29, 1985
- Decision date
- September 18, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1695
- Specialty
- Clinical Chemistry
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Questions and answers
When was Simultrac Free T4(57CO)/TSH[125I] Radioimmunoassay cleared by the FDA?
Simultrac Free T4(57CO)/TSH[125I] Radioimmunoassay (K853628) received a 510(k) decision of Substantially Equivalent on September 18, 1985, 20 days after the submission was received.
What is the product code of K853628?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.