Atlas FDA

RANDOX C-REACTIVE PROTEIN

FDA 510(k) clearance K001009 · decided 2000-08-04

Clearance details

K-number
K001009
Device name
RANDOX C-REACTIVE PROTEIN
Applicant
Randox Laboratories, Ltd.
Decision
Substantially Equivalent
Date received
2000-03-29
Decision date
2000-08-04
Days to decision
128 days
Clearance type
Traditional
Product code
DCK
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Crumlin, Co. Antrim, GB
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. recall (Z-0295-04)Polymedco, Inc2004-01-06
POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x recall (Z-0296-04)Polymedco, Inc2004-01-06