510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K854805Substantially Equivalent

Allegro Prolactin Immunoassay System

Nichols Institute Diagnostics, Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854805 is the FDA 510(k) clearance record for ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM, a class I device, cleared for Nichols Institute Diagnostics on under FDA product code CFT (Radioimmunoassay, Prolactin (Lactogen)). FDA records list 68 510(k) clearances for Nichols Institute Diagnostics, from to . As of , FDA records show no recalls naming K854805.

Clearance record

Decision date
Received
(57 days to decision)
Product code
CFT Radioimmunoassay, Prolactin (Lactogen)
Regulation
21 CFR 862.1625
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Nichols Institute Diagnostics P.O. Box 92797, Los Angeles CA
Third party review
No

Clearances, product code CFT

Trailing 12 months

FDA records hold no clearances under product code CFT in the trailing twelve months.

FDA records show no clearances under product code CFT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CFT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260