510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K863841Substantially Equivalent

Tandem OTC Hcg Pregnancy Test for Consumer Use

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

K863841 is the FDA 510(k) clearance record for TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE, a class II device, cleared for Hybritech, Inc. on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 63 510(k) clearances for Hybritech, Inc., from to . As of , FDA records show no recalls naming K863841.

Clearance record

Decision date
Received
(82 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
Hybritech, Inc. 11095 Torreyana Rd., San Diego CA
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