510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060452Substantially Equivalent

Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015Xx-Ecah

Neo-Genesis, Portland OR / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060452 is the FDA 510(k) clearance record for ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH, a class I device, cleared for Neo-Genesis on under FDA product code JLX (Radioimmunoassay, 17-Hydroxyprogesterone). FDA records list one 510(k) clearance for Neo-Genesis. As of , FDA records show no recalls naming K060452.

Clearance record

Decision date
Received
(385 days to decision)
Product code
JLX Radioimmunoassay, 17-Hydroxyprogesterone
Regulation
21 CFR 862.1395
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Neo-Genesis 4814 NE 107th Ave., Portland OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JLX

Trailing 12 months

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

FDA records show no clearances under product code JLX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JLX, 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