Atlas FDA

DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

FDA 510(k) clearance K972782 · decided 1997-08-15

Clearance details

K-number
K972782
Device name
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
Applicant
Dade Intl., Inc.
Decision
Substantially Equivalent
Date received
1997-07-25
Decision date
1997-08-15
Days to decision
21 days
Clearance type
Traditional
Product code
JHX
Device class
2
Regulation number
862.1215
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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PATHFAST CK-MB-II, PATHFAST MYO-II (K081360)Mitsubishi Kagaku Iatron2009-08-17
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. (K051650)Dade Behring, Inc.2005-09-08
ARCHITECT STAT CK-MB IMMUNOASSAY (K041596)Fisher Diagnostics2004-07-21
RAMP CK-MB ASSAY (K033747)Response Biomedical Corp.2004-05-17
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (K034055)Diagnostic Products Corp.2004-01-21
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 (K030012)Beckman Coulter, Inc.2003-01-17
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (K022118)Diagnostic Products Corp.2002-07-22
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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