Atlas FDA

DADE TRU-LIQUID CARDIAC CONTROL

FDA 510(k) clearance K973974 · decided 1997-11-06

Clearance details

K-number
K973974
Device name
DADE TRU-LIQUID CARDIAC CONTROL
Applicant
Dade Intl., Inc.
Decision
Substantially Equivalent
Date received
1997-10-20
Decision date
1997-11-06
Days to decision
17 days
Clearance type
Traditional
Product code
JJT
Device class
1
Regulation number
862.1660
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Miami, FL, US
Third-party review
No
Expedited review
No

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RecordFirmDate
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED (K090940)Astoria-Pacific, Inc.2009-12-14
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER (K062751)Quantimetrix Corp.2006-10-03
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL (K030768)Cliniqa Corporation2003-03-21
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 (K030102)Bayer Healthcare, LLC2003-01-24
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL (K021498)Bio-Rad2002-05-24
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 (K012656)Bio-Rad2001-09-06
CARDIASURE CARDIAC MARKERS CONTROL (K993723)Quantimetrix Corp.1999-11-23
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (K993715)Seracare Technology1999-11-16
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (K992430)Medical Analysis Systems, Inc.1999-08-30
QUANTEX ASO-CRP-RP CONTROL II (K984437)Instrumentation Laboratory CO1999-02-02
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (K984277)Medical Analysis Systems, Inc.1998-12-09
CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 (K982845)More Diagnostics1998-08-21

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