Atlas FDA

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k) clearance K073640 · decided 2008-04-24

Clearance details

K-number
K073640
Device name
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
Applicant
Axis-Shield Diagnostics, Ltd.
Decision
Substantially Equivalent
Date received
2007-12-26
Decision date
2008-04-24
Days to decision
120 days
Clearance type
Traditional
Product code
LPS
Device class
2
Regulation number
862.1377
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Dundee, GB
Third-party review
No
Expedited review
No

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RecordFirmDate
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AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (K112790)Axis-Shield Diagnostics, Ltd.2012-05-07
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DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL (K071971)Diazyme Laboratories2007-09-17
TECO HOMOCYSTEINE ENZYMATIC ASSAY (K063701)Teco Diagnostics2007-04-11
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH (K063206)Dade Behring, Inc.2006-12-28
LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT (K062808)Catch Incorporated2006-10-13
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Recalls involving this device

No recalls on record reference this clearance.