510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K962219Substantially Equivalent

Quickstick One Step Pregnancy Test(9010)

Phamatech Inc., Sandiego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962219 is the FDA 510(k) clearance record for QUICKSTICK ONE STEP PREGNANCY TEST(9010), a class II device, cleared for Phamatech on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 62 510(k) clearances for Phamatech, from to . As of , FDA records show no recalls naming K962219.

Clearance record

Decision date
Received
(43 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
Phamatech 9265 Activity Rd., Sandiego CA
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260