DPC Coat-A-Count Irma LH Kit
FDA 510(k) K863934 · Diagnostic Products Corp.
510(k) numberK863934
Submission
- Device name
- DPC Coat-A-Count Irma LH Kit
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- October 9, 1986
- Decision date
- February 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEP – Radioimmunoassay, Luteinizing Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1485
- Specialty
- Clinical Chemistry
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Questions and answers
When was DPC Coat-A-Count Irma LH Kit cleared by the FDA?
DPC Coat-A-Count Irma LH Kit (K863934) received a 510(k) decision of Substantially Equivalent on February 6, 1987, 120 days after the submission was received.
What is the product code of K863934?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.