Atlas FDA

INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET

FDA 510(k) clearance K934039 · decided 1993-11-16

Clearance details

K-number
K934039
Device name
INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
Applicant
Intersect Systems, Inc.
Decision
Substantially Equivalent
Date received
1993-08-18
Decision date
1993-11-16
Days to decision
90 days
Clearance type
Traditional
Product code
LBR
Device class
1
Regulation number
862.1475
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Longview, WA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
LDLC3 LDL-Cholesterol Gen.3 (K143691)Roche Diagnostics Operations (Rdo)2015-01-28
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (K072523)General Atomics2008-01-22
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (K050823)Teco Diagnostics2005-07-26
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER (K023784)Hemagen Diagnostics, Inc.2002-12-24
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K012593)Ortho-Clinical Diagnostics, Inc.2001-08-30
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K992029)Elan Diagnostics1999-08-12
AUTOHDL CHOLESTEROL REAGENT SET (K992002)Pointe Scientific, Inc.,1999-08-05
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K991789)Elan Holdings, Inc.1999-07-09
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (K990247)Polymer Technology Systems, Inc.1999-05-28
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (K984303)Ortho-Clinical Diagnostics, Inc.1999-01-28
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 (K980772)Diagnostic Chemicals , Ltd.1998-04-27
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 (K980770)Diagnostic Chemicals , Ltd.1998-04-21

Recalls involving this device

No recalls on record reference this clearance.