Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

52 results for "Hemagen Diagnostics, Inc."
1–24 of 52
Search insights Median review: 60d Cleared: 100% Top manufacturer: Hemagen Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 30, 2004
RAICHEM GLUCOSE UV (LIQUID)
K041052 · CFR
Hemagen Diagnostics, Inc.
Chemistry · 72d
Cleared Jun 30, 2004
RAICHEM BUN RATE REAGENT (LIQUID)
K041051 · CDQ
Hemagen Diagnostics, Inc.
Chemistry · 72d
Cleared Jun 25, 2004
RAICHEM CALCIUM (OCPC) LIQUID REAGENT
K041009 · CIC
Hemagen Diagnostics, Inc.
Chemistry · 67d
Cleared Jun 16, 2003
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
K031101 · JJY
Hemagen Diagnostics, Inc.
Chemistry · 70d
Cleared Dec 24, 2002
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS...
K023784 · LBR
Hemagen Diagnostics, Inc.
Chemistry · 42d
Cleared Sep 17, 2002
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
K022772 · MRR
Hemagen Diagnostics, Inc.
Chemistry · 27d
Cleared Sep 03, 2002
RAICHEM LIPID CALIBRATOR
K022767 · JIX
Hemagen Diagnostics, Inc.
Chemistry · 13d
Cleared Jul 29, 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194 · DCK
Hemagen Diagnostics, Inc.
Chemistry · 105d
Cleared Jul 19, 2002
MODIFICATION TO RAICHEM CALCIUM REAGENT
K022049 · CJY
Hemagen Diagnostics, Inc.
Chemistry · 25d
Cleared Oct 15, 2001
RAICHEM GLUCOSE UV REAGENT
K012668 · CFR
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Oct 15, 2001
RAICHEM BUN RATE REAGENT
K012649 · CDQ
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Sep 24, 2001
RAICHEM MULTI-ANALYTE CALIBRATOR
K012250 · JIX
Hemagen Diagnostics, Inc.
Chemistry · 69d
Cleared May 21, 2001
ANALYST PANELS + ANALYTICAL TEST ROTOR
K010864 · KHS
Hemagen Diagnostics, Inc.
Chemistry · 60d
Cleared May 02, 2001
RAICHEM CREATININE URINE STANDARD
K011126 · JIT
Hemagen Diagnostics, Inc.
Chemistry · 19d
Cleared Oct 25, 2000
RAICHEM PHOSPORUS REAGENT
K003012 · CEO
Hemagen Diagnostics, Inc.
Chemistry · 29d
Cleared Aug 30, 1999
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
K992243 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
K992241 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
K992224 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Nov 13, 1997
VIRGO PANCO KIT
K973824 · MOB
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared Nov 13, 1997
PR 3 ANTIBODY KIT
K973823 · MOB
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared Nov 13, 1997
VIRGO ANCA SCREEN KIT
K973822 · MOB
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared Aug 28, 1997
RAICHEM PREALBUMIN SPIA
K972812 · DDS
Hemagen Diagnostics, Inc.
Immunology · 31d
Cleared Jun 20, 1997
VIRGO AMA ELISA KIT
K971909 · DBM
Hemagen Diagnostics, Inc.
Immunology · 28d
Cleared Jun 03, 1997
HEMAGEN ANTI CARDIOLIPIN SCREEN
K971039 · MID
Hemagen Diagnostics, Inc.
Immunology · 74d