Ria Diag. Test Kit for Indexing Thyrox.
FDA 510(k) K781560 · Nuclear Diagnostics, Inc.
510(k) numberK781560
Submission
- Device name
- Ria Diag. Test Kit for Indexing Thyrox.
- Applicant
- Nuclear Diagnostics, Inc.
Mchenry, IL, US - Received
- September 11, 1978
- Decision date
- October 17, 1978
- 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 Ria Diag. Test Kit for Indexing Thyrox. cleared by the FDA?
Ria Diag. Test Kit for Indexing Thyrox. (K781560) received a 510(k) decision of Substantially Equivalent on October 17, 1978, 36 days after the submission was received.
What is the product code of K781560?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.