510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K854104Substantially Equivalent

Immuchem V.i.p.(visual Indicated Pregnancy)

Immunchem Corp., Carson CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854104 is the FDA 510(k) clearance record for IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY), a class II device, cleared for Immunchem Corp. on under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use). FDA records list one 510(k) clearance for Immunchem Corp. As of , FDA records show no recalls naming K854104.

Clearance record

Decision date
Received
(58 days to decision)
Product code
JHI Visual, Pregnancy Hcg, Prescription Use
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Immunchem Corp. 20770 Leapwood Ave., Carson CA
Third party review
No

Clearances, product code JHI

Trailing 12 months
1 clearance under product code JHI in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JHI, 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 20261
October 20260