APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE

FDA 510(k) clearance K141220 · decided 2014-05-22

Clearance details

K-number: K141220
Device name: APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
Applicant: Thermo Fisher Scientific (Life Technologies Holdin
Decision: Substantially Equivalent
Date received: 2014-05-12
Decision date: 2014-05-22
Days to decision: 10 days
Clearance type: Special
Product code: NSU
Device class: 2
Regulation number: 862.2570
Medical specialty: Clinical Chemistry
Advisory committee: Clinical Chemistry
Location: Singapore, SG
Third-party review: No
Expedited review: No

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

Record	Firm	Date
ePlex Instrument (K163652)	Genmark Diagnostics, Incorporated	2017-06-09
FilmArray 2.0 System (K143178)	Biofire Diagnostics, LLC	2015-01-30
VANTERA CLINICAL ANALYZER (K133849)	Liposcience	2014-10-22
FLEXMAP 3D (K133302)	Luminex Corp.	2014-01-10
LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P (K121399)	Luminex Corp.	2013-01-09
ESENSOR WARFARIN SENSITIVITY SALIVA TEST (K110786)	GenMark Diagnostics, Inc.	2011-12-02
ILLUMINA BEADXPRESS SYSTEM (K093128)	Illumina, Inc.	2010-04-28
APPLIED BIOSYSTEMS 7500 FAST DX (K082562)	Applied Biosystems, Inc.	2008-09-30
MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM (K080995)	Affymetrix, Inc.	2008-07-30
LUMINEX LX 100/200 INSTRUMENT (K073506)	Luminex Corp.	2008-03-07
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST (K070597)	Nanosphere, Inc.	2007-10-11
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM (DEN040012)	Affymetrix, Inc.	2004-12-23

No recalls on record reference this clearance.