510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950354Substantially Equivalent

Human Chorionic Gonadotropin (Hcg) Test System for the Early Detection of Pregnancy

Ml Strategies, Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950354 is the FDA 510(k) clearance record for HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY, a class II device, cleared for Ml Strategies, Inc. on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 4 510(k) clearances for Ml Strategies, Inc., from to . As of , FDA records show no recalls naming K950354.

Clearance record

Decision date
Received
(170 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
Ml Strategies, Inc. One Financial Center, Boston MA
510(k) summary
Statement
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