Atlas FDA

VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS

FDA 510(k) clearance K033300 · decided 2003-11-05

Clearance details

K-number
K033300
Device name
VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2003-10-14
Decision date
2003-11-05
Days to decision
22 days
Clearance type
Traditional
Product code
DDR
Device class
2
Regulation number
866.5680
Medical specialty
Immunology
Advisory committee
Immunology
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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ARCHITECT STAT MYO IMMUNOASSAY (K042924)Fisher Diagnostics2005-01-24
QUANTEX MYOGLOBIN (K042982)Instrumentation Laboratory CO2004-12-22
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RAMP MYOGLOBIN ASSAY (K012040)Response Biomedical Corp.2001-12-18
RANDOX MYOGLOBIN (K010700)Randox Laboratories, Ltd.2001-05-08
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VITROS Anti-HBc IgM (P030026/S037)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036)Ortho-Clinical Diagnostics, Inc.2020-10-22
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033)Ortho-Clinical Diagnostics, Inc.2020-08-07
VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19