Cobas Core Free T3 Eia
FDA 510(k) K942376 · Roche Diagnostic Systems, Inc.
510(k) numberK942376
Submission
- Device name
- Cobas Core Free T3 Eia
- Applicant
- Roche Diagnostic Systems, Inc.
Branchburg, NJ, US - Received
- May 18, 1994
- Decision date
- April 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Cobas Core Free T3 Eia cleared by the FDA?
Cobas Core Free T3 Eia (K942376) received a 510(k) decision of Substantially Equivalent on April 21, 1995, 338 days after the submission was received.
What is the product code of K942376?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.