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JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use Class I

FDA Device Classification

FDA product code JJQ covers "Colorimeter, Photometer, Spectrophotometer For Clinical Use", a Class I medical device regulated under 21 CFR 862.2300. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JJQ
Device Class
Class I
Regulation Number
862.2300
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K013371Otsuka Pharmaceutical CoUBIT-IR300 INFRARED SPECTROMETRY SYSTEMDec 21, 2001
K980120DigeneDIGENE DML 2000 MICROPLATE LUMINOMETERFeb 6, 1998
K973938SfriALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERFeb 4, 1998
K974762Awareness TechnologySTAT TRACKSJan 28, 1998
K962113Columbia BioscienceANTHOS PHACTS VERSION MICROPLATE READERNov 5, 1996
K961183Columbia BioscienceCBI 7520 READERAug 2, 1996
K962166IgenORIGEN ANALYZERJul 31, 1996
K955077Anthos LabtecANTHOS 2010 READERDec 4, 1995
K953710Bio-Tek InstrumentsELX808 AUTOMATED MICROPLATE READERSOct 25, 1995
K953572Bio-Tek InstrumentsELX800UVOct 19, 1995
K953005Olympic MedicalBILI-METERSep 28, 1995
K950029Nichols Institute Diagnostics5STRATEC SL 300 LIA-MATAug 2, 1995
K940486Digene DiagnosticsDIGENE DCR-1 LUMINOMETERApr 18, 1995
K942361Biowhittaker Molecular ApplicationsWHITSOFTApr 4, 1995
K942250Biowhittaker Molecular ApplicationsBIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READERApr 4, 1995
K942245Biowhittaker Molecular ApplicationsBIOWHITTAKER 2001 MICROPLATE READER FIRMWAREApr 3, 1995
K950104Bio-Tek InstrumentsELX800 AND EL800 AUTOMATED MICROPLATE READERSMar 21, 1995
K942923Bio-Tek InstrumentsCERES 900C & CERES UV900CFeb 6, 1995
K943454RosysPLATO 3300/1300Jan 9, 1995
K935983HyperionMICROREADER 4Dec 9, 1994

FDA data resources