510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K100682Substantially Equivalent

Gsp Neonatal 17A-Oh-Progesterone Kit Model: 3305-001U

Wallac Oy, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100682 is the FDA 510(k) clearance record for GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U, a class I device, cleared for Wallac OY on under FDA product code JLX (Radioimmunoassay, 17-Hydroxyprogesterone). FDA records list 24 510(k) clearances for Wallac OY, from to . As of , FDA records show no recalls naming K100682.

Clearance record

Decision date
Received
(135 days to decision)
Product code
JLX Radioimmunoassay, 17-Hydroxyprogesterone
Regulation
21 CFR 862.1395
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Wallac OY 8275 Carloway Rd., Indianapolis IN
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