510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K053138Substantially Equivalent

Myset Pregnancy Test

Ani Biotech Oy, Beverly MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053138 is the FDA 510(k) clearance record for MYSET PREGNANCY TEST, a class II device, cleared for Ani Biotech OY on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list one 510(k) clearance for Ani Biotech OY. As of , FDA records show no recalls naming K053138.

Clearance record

Decision date
Received
(112 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
Ani Biotech OY 163 Cabot St., Beverly MA
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