510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K123050Substantially Equivalent

Egens One Step Hcg Urine Pregnancy Test Kit(s) (Strip, Cassette, Midstream I and Midstream II)

Nantong Biotechnology Co., Ltd., Gaithersburg MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123050 is the FDA 510(k) clearance record for EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II), a class II device, cleared for Nantong Biotechnology Co., Ltd. on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list one 510(k) clearance for Nantong Biotechnology Co., Ltd. As of , FDA records show no recalls naming K123050.

Clearance record

Decision date
Received
(130 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
Nantong Biotechnology Co., Ltd. 12828 Doe Ln., Gaithersburg MD
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