ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM— 510(k) K854805

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K854805 for ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM, Substantially Equivalent on 1986-01-28. Applicant: Nichols Institute Diagnostics. Device class: 1.

Clearance details

Applicant
Nichols Institute Diagnostics
Product code
Code CFT
Device class
Class 1
Regulation
21 CFR 862.1625
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Los Angeles, CA, US
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