Luteinizing Hormone Mab Solid Phase Component Syst
FDA 510(k) K894279 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK894279
Submission
- Device name
- Luteinizing Hormone Mab Solid Phase Component Syst
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- June 23, 1989
- Decision date
- August 15, 1989
- 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 Luteinizing Hormone Mab Solid Phase Component Syst cleared by the FDA?
Luteinizing Hormone Mab Solid Phase Component Syst (K894279) received a 510(k) decision of Substantially Equivalent on August 15, 1989, 53 days after the submission was received.
What is the product code of K894279?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.