Terumo Sensibead(Tm) Eia HLH Kit
FDA 510(k) K863929 · Terumo Medical Corp.
510(k) numberK863929
Submission
- Device name
- Terumo Sensibead(Tm) Eia HLH Kit
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- October 8, 1986
- Decision date
- November 13, 1986
- 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 Terumo Sensibead(Tm) Eia HLH Kit cleared by the FDA?
Terumo Sensibead(Tm) Eia HLH Kit (K863929) received a 510(k) decision of Substantially Equivalent on November 13, 1986, 36 days after the submission was received.
What is the product code of K863929?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.