510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K970082Substantially Equivalent

Abbott Advisor One-Step Pregnancy Test

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970082 is the FDA 510(k) clearance record for ABBOTT ADVISOR ONE-STEP PREGNANCY TEST, a class II device, cleared for Abbott Laboratories on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K970082.

Clearance record

Decision date
Received
(15 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
Abbott Laboratories 100 Abbott Park Rd. D49c, Abbott Park IL
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