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
K210341Substantially Equivalent

One Step Pregnancy Test

SPD Swiss Precision Diagnostics GmbH, Geneva, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210341 is the FDA 510(k) clearance record for One Step Pregnancy Test, a class II device, cleared for Spd Swiss Precision Diagnostics GmbH on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 4 510(k) clearances for Spd Swiss Precision Diagnostics GmbH, from to . As of , FDA records show no recalls naming K210341.

Clearance record

Decision date
Received
(398 days to decision)
Product code
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Spd Swiss Precision Diagnostics GmbH 47 Rte. De Saint Georges, Petit-Lancy, Geneva, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCX

Trailing 12 months

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

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