Atlas FDA

CRP DIAGNOSTIC ASSAY

FDA 510(k) clearance K050836 · decided 2005-08-08

Clearance details

K-number
K050836
Device name
CRP DIAGNOSTIC ASSAY
Applicant
Sentinel Ch. Srl
Decision
Substantially Equivalent
Date received
2005-04-01
Decision date
2005-08-08
Days to decision
129 days
Clearance type
Traditional
Product code
DCK
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Rome, IT
Third-party review
No
Expedited review
No

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VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (K152433)Ortho Clinical Diagnostics2015-09-24
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit (K141689)Qualigen, Inc.2015-01-07
DIAZYME HSCRP POC TEST KIT (K121558)Diazyme Laboratories2012-09-21
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET (K103557)Diazyme Laboratories2011-04-27
ABX PENTRA 400 : CRP (K061138)Horiba Abx2006-09-29

Recalls involving this device

No recalls on record reference this clearance.