510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883826Substantially Equivalent

Home Clinic Pregnancy Test

Vanguard Biomedical Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883826 is the FDA 510(k) clearance record for HOME CLINIC PREGNANCY TEST, a class II device, cleared for Vanguard Biomedical Corp. on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 10 510(k) clearances for Vanguard Biomedical Corp., from to . As of , FDA records show no recalls naming K883826.

Clearance record

Decision date
Received
(81 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
Vanguard Biomedical Corp. 7822 Convoy Ct., 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