Atlas FDA

RANDOX IRON

FDA 510(k) clearance K974604 · decided 1998-01-06

Clearance details

K-number
K974604
Device name
RANDOX IRON
Applicant
Randox Laboratories, Ltd.
Decision
Substantially Equivalent
Date received
1997-12-10
Decision date
1998-01-06
Days to decision
27 days
Clearance type
Traditional
Product code
JMO
Device class
1
Regulation number
862.1415
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Crumlin, Co. Antrim, IE
Third-party review
No
Expedited review
No

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TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (K991666)A.P. Total Care, Inc.1999-06-30
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Recalls involving this device

No recalls on record reference this clearance.