Atlas FDA

LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648

FDA 510(k) clearance K012656 · decided 2001-09-06

Clearance details

K-number
K012656
Device name
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
Applicant
Bio-Rad
Decision
Substantially Equivalent
Date received
2001-08-13
Decision date
2001-09-06
Days to decision
24 days
Clearance type
Traditional
Product code
JJT
Device class
1
Regulation number
862.1660
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Bio-Rad

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

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
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
LIQUICHEK CARDIAC MARKERS CONTROL LT (K980556)Bio-Rad1998-02-25

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002)Bio-Rad1996-03-01
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001)Bio-Rad1991-03-14
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032)Bio-Rad1989-07-24