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ARCHITECT STAT MYO IMMUNOASSAY

FDA 510(k) clearance K042924 · decided 2005-01-24

Clearance details

K-number
K042924
Device name
ARCHITECT STAT MYO IMMUNOASSAY
Applicant
Fisher Diagnostics
Decision
Substantially Equivalent
Date received
2004-10-22
Decision date
2005-01-24
Days to decision
94 days
Clearance type
Traditional
Product code
DDR
Device class
2
Regulation number
866.5680
Medical specialty
Immunology
Advisory committee
Immunology
Location
Middletown, VA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
Access Myoglobin (K231832)Beckman Coulter, Inc.2023-09-18
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QUANTEX MYOGLOBIN (K042982)Instrumentation Laboratory CO2004-12-22
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS (K033300)Ortho-Clinical Diagnostics, Inc.2003-11-05
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RAMP MYOGLOBIN ASSAY (K012040)Response Biomedical Corp.2001-12-18
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Recalls involving this device

RecordFirmDate
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. recall (Z-1476-2024)Abbott Laboratories2024-04-04