510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011126Substantially Equivalent

Raichem Creatinine Urine Standard

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

K011126 is the FDA 510(k) clearance record for RAICHEM CREATININE URINE STANDARD, a class II device, cleared for Hemagen Diagnostics, Inc. on under FDA product code JIT (Calibrator, Secondary). FDA records list 52 510(k) clearances for Hemagen Diagnostics, Inc., from to . As of , FDA records show no recalls naming K011126.

Clearance record

Decision date
Received
(19 days to decision)
Product code
JIT Calibrator, Secondary
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hemagen Diagnostics, Inc. 9033 Red Branch Rd., Columbia MD
510(k) summary
Statement
Third party review
No

Clearances, product code JIT

Trailing 12 months

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

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