Dispenser, Technetium, Clintichem
FDA 510(k) K770515 · Union Carbide Corp.
510(k) numberK770515
Submission
- Device name
- Dispenser, Technetium, Clintichem
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- March 17, 1977
- Decision date
- April 5, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Dispenser, Technetium, Clintichem cleared by the FDA?
Dispenser, Technetium, Clintichem (K770515) received a 510(k) decision of Substantially Equivalent on April 5, 1977, 19 days after the submission was received.
What is the product code of K770515?
The FDA product code is KPT – Calibrator, Dose, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1360.