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
K030533Substantially Equivalent

Accunate One-Step,accunate One-Step Cassette, Accunate-Choice, Accunate Home Pregnancy Test

Cenogenics Corp., Morganville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030533 is the FDA 510(k) clearance record for ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST, a class II device, cleared for Cenogenics Corp. on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 5 510(k) clearances for Cenogenics Corp., from to . As of , FDA records show no recalls naming K030533.

Clearance record

Decision date
Received
(62 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
Cenogenics Corp. 100 Rt. 520, Morganville NJ
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