Atlas FDA

PATHFAST HSCRP

FDA 510(k) clearance K083412 · decided 2009-03-09

Clearance details

K-number
K083412
Device name
PATHFAST HSCRP
Applicant
Mitsubishi Kagaku Iatron
Decision
Substantially Equivalent
Date received
2008-11-18
Decision date
2009-03-09
Days to decision
111 days
Clearance type
Traditional
Product code
DCN
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Seattle, WA, US
Third-party review
No
Expedited review
No

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C-Reactive Protein Kit for use on SPAPLUS (K161982)The Binding Site Group2017-04-05
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (K113809)Hitachi Chemical Diagnostics, Inc.2012-08-17
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (K091052)Abaxis, Inc.2010-01-15
C-REACTIVE PROTEIN (LATEX) (K083444)Roche Diagnostics Corp.2009-03-18
S-TEST C-REACTIVE PROTEIN (CRP) (K083040)Alfa Wassermann Diagnostic Technologies, Inc.2009-01-30
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS (K072658)Siemens Medical Solutions Diagnostics2008-04-01

Recalls involving this device

No recalls on record reference this clearance.