Atlas FDA

ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01

FDA 510(k) clearance K072393 · decided 2007-12-07

Clearance details

K-number
K072393
Device name
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
Applicant
Phadia US, Inc.
Decision
Substantially Equivalent
Date received
2007-08-27
Decision date
2007-12-07
Days to decision
102 days
Clearance type
Traditional
Product code
LSW
Device class
2
Regulation number
866.5100
Medical specialty
Immunology
Advisory committee
Immunology
Location
Portage, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG recall (Z-1107-2021)Phadia US Inc2021-02-11