Atlas FDA

STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY

FDA 510(k) clearance K965213 · decided 1997-02-10

Clearance details

K-number
K965213
Device name
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
Applicant
Dade Intl., Inc.
Decision
Substantially Equivalent
Date received
1996-12-30
Decision date
1997-02-10
Days to decision
42 days
Clearance type
Traditional
Product code
DDR
Device class
2
Regulation number
866.5680
Medical specialty
Immunology
Advisory committee
Immunology
Location
Miami, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Access Myoglobin (K231832)Beckman Coulter, Inc.2023-09-18
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET (K123785)Diazyme Laboratories2013-06-07
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR (K122599)Siemens Healthcare Diagnostics, Inc.2012-10-03
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (K083260)Roche Diagnostics2009-10-16
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS (K080481)Beckman Coulter, Inc.2009-02-20
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM (K061683)Roche Diagnostics Corp.2006-07-21
ARCHITECT STAT MYO IMMUNOASSAY (K042924)Fisher Diagnostics2005-01-24
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
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 (K021229)Beckman Coulter, Inc.2002-06-28
RAMP MYOGLOBIN ASSAY (K012040)Response Biomedical Corp.2001-12-18
RANDOX MYOGLOBIN (K010700)Randox Laboratories, Ltd.2001-05-08

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS (P870049/S032)Dade Intl., Inc.2001-11-30
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S031)Dade Intl., Inc.2001-11-09
MICROSCAN(R) RAPID FLUOROGENIC PANELS (P870049/S030)Dade Intl., Inc.2000-06-05
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S029)Dade Intl., Inc.1999-06-24
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S028)Dade Intl., Inc.1999-01-25
MICROSCAN(R) RAPID FLUOROGENIC PANELS (P870049/S027)Dade Intl., Inc.1998-06-30
MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS (P870049/S025)Dade Intl., Inc.1996-05-03
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S024)Dade Intl., Inc.1996-03-12