Coat-A-Count No-Extraction Testosterone
FDA 510(k) K831342 · Diagnostic Products Corp.
510(k) numberK831342
Submission
- Device name
- Coat-A-Count No-Extraction Testosterone
- Applicant
- Diagnostic Products Corp.
Mchenry, IL, US - Received
- April 25, 1983
- Decision date
- June 2, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1680
- Specialty
- Clinical Chemistry
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Questions and answers
When was Coat-A-Count No-Extraction Testosterone cleared by the FDA?
Coat-A-Count No-Extraction Testosterone (K831342) received a 510(k) decision of Substantially Equivalent on June 2, 1983, 38 days after the submission was received.
What is the product code of K831342?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.