Atlas FDA

OLYMPUS LIPASE REAGENT

FDA 510(k) clearance K963424 · decided 1997-01-14

Clearance details

K-number
K963424
Device name
OLYMPUS LIPASE REAGENT
Applicant
Olympus America, Inc.
Decision
Substantially Equivalent
Date received
1996-08-30
Decision date
1997-01-14
Days to decision
137 days
Clearance type
Traditional
Product code
CDT
Device class
1
Regulation number
862.1705
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Melville, NY, 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
Triglycerides (K150819)Randox Laboratories Limited2015-08-06
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (K133067)Siemens Healthcare Diagnostics, Inc.2013-11-22
VITROS CHEMISTRY PRODUCTS TRIG SLIDES (K130332)Ortho-Clinical Diagnostics, Inc.2013-05-31
VANTERA CLINICAL ANALYZER (K113830)Liposcience2012-08-30
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL (K102993)Seppim S.A.S.2011-05-19
OLYMPUS TRIGLYCERIDE TEST SYSTEM (K063804)Olympus America, Inc.2007-03-23
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (K043546)Dade Behring, Inc.2005-01-18
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (K034000)Clinical Data, Inc.2004-03-10
CARESIDE TRGLYCERIDE (K020488)Careside, Inc.2002-04-15
TGL FLEX REAGENT CARTRIDGE (K010871)Dade Behring, Inc.2001-07-09
WAKO L-TYPE TRIGLYCERIDE TEST (K993466)Wako Chemicals USA, Inc.1999-11-09
TRIGLYCERIDES, TG, OR TRIG (K971324)Carolina Liquid Chemistries Corp.1997-06-20

Recalls involving this device

RecordFirmDate
Beckman Coulter, Lipase Assay, Catalog No. OSR6X30 recall (Z-1023-2015)Beckman Coulter Inc.2015-01-28