510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K831051Substantially Equivalent

Home Pregnancy Test Kit Hpk #1

Ortho-Clinical Diagnostics, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831051 is the FDA 510(k) clearance record for HOME PREGNANCY TEST KIT HPK #1, a class II device, cleared for Quidel Corp. on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K831051.

Clearance record

Decision date
Received
(47 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
Quidel Corp. 1730 Pennsylvania Ave., NW, Washington DC
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