510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K052598Substantially Equivalent

Immocare

Care Diagnostic, Inc., Klamath Falls OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K052598 is the FDA 510(k) clearance record for IMMOCARE, a class II device, cleared for Care Diagnostic, Inc. on under FDA product code KHE (Reagent, Occult Blood). FDA records list one 510(k) clearance for Care Diagnostic, Inc. As of , FDA records show no recalls naming K052598.

Clearance record

Decision date
Received
(176 days to decision)
Product code
KHE Reagent, Occult Blood
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Care Diagnostic, Inc. 1741 Wiard St., Klamath Falls OR
510(k) summary
Statement
Third party review
No

Clearances, product code KHE

Trailing 12 months

FDA records hold no clearances under product code KHE in the trailing twelve months.

FDA records show no clearances under product code KHE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHE, 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