510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K980532Substantially Equivalent

Quickstream One Step Pregnancy Test Model Number 9012

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

K980532 is the FDA 510(k) clearance record for QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012, 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 K980532.

Clearance record

Decision date
Received
(28 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., #112-113, San Diego CA
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 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