510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021194Substantially Equivalent

Raichem Crp High Sensitivity Test System

Hemagen Diagnostics, Inc., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K021194 is the FDA 510(k) clearance record for RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM, a class II device, cleared for Hemagen Diagnostics, Inc. on under FDA product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control). FDA records list 52 510(k) clearances for Hemagen Diagnostics, Inc., from to . As of , FDA records show no recalls naming K021194.

Clearance record

Decision date
Received
(105 days to decision)
Product code
DCK C-Reactive Protein, Antigen, Antiserum, And Control
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Hemagen Diagnostics, Inc. 9033 Red Branch Rd., Columbia MD
510(k) summary
Statement
Third party review
No

Clearances, product code DCK

Trailing 12 months

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

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