Allegro(Tm) Luteinizing Hormone Immunoassay
FDA 510(k) K881124 · Nichols Institute Diagnostics
510(k) numberK881124
Submission
- Device name
- Allegro(Tm) Luteinizing Hormone Immunoassay
- Applicant
- Nichols Institute Diagnostics
Los Angeles, CA, US - Received
- March 16, 1988
- Decision date
- April 18, 1988
- 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 Allegro(Tm) Luteinizing Hormone Immunoassay cleared by the FDA?
Allegro(Tm) Luteinizing Hormone Immunoassay (K881124) received a 510(k) decision of Substantially Equivalent on April 18, 1988, 33 days after the submission was received.
What is the product code of K881124?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.