ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY— 510(k) K881124
Substantially EquivalentNichols Institute Diagnostics
FDA 510(k) clearance K881124 for ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY, Substantially Equivalent on 1988-04-18. Applicant: Nichols Institute Diagnostics. Device class: 1.
Clearance details
- Applicant
- Nichols Institute Diagnostics
- Product code
- Code CEP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code CEP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.