510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K874388Substantially Equivalent

Kodak Surecell(tm) Hcg-Urine Kit

Eastman Kodak Company, Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874388 is the FDA 510(k) clearance record for KODAK SURECELL(TM) HCG-URINE KIT, a class II device, cleared for Eastman Kodak Company on under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use). FDA records list 291 510(k) clearances for Eastman Kodak Company, from to . As of , FDA records show no recalls naming K874388.

Clearance record

Decision date
Received
(104 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
Eastman Kodak Company 343 State St., Rochester NY
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