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JJC — Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use Class I

FDA Device Classification

Classification Details

Product Code
JJC
Device Class
Class I
Regulation Number
862.2150
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K945915avl scientificAVL OMNI ANALYZERApril 5, 1995
K945584nova biomedicalNOVA 16 ANALYZERFebruary 8, 1995
K943376milesOPERA SYSTEMSeptember 14, 1994
K901410technicon instrumentsTECHNICON RA-2000(TM) SYSTEMJuly 17, 1990
K901141baxter healthcarePARAMAX 520, PARAMAX 720 AND PARAMAX 720ZXApril 9, 1990
K890332alpkemRFA/2 RAPID FLOW ANALYZER W/COMPUTERFebruary 17, 1989
K881056american research productsAMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030November 15, 1988
K875105technicon instrumentsTECHNICON SMAC 3 SYSTEMFebruary 16, 1988
K870998technicon instrumentsTECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYSMay 26, 1987
K862561technicon instrumentsTECHNICON RA-XT SYSTEM WITH ANALYTESOctober 20, 1986
K854345technicon instrumentsTECHNICON RA-500 SYSTEMNovember 26, 1985
K852306methodist hospital of memphisREPLACEMENT REAGENTS FOR SMAC II SYSTEMSAugust 2, 1985
K833157sherwood medicalLANCER ANALYZER CUPSDecember 8, 1983
K833023technicon instrumentsTECHNICON RA-1000 SYSTEMNovember 3, 1983
K823233gilford instrument laboratoriesSBA 300 CLINICAL CHEMISTRY ANALYZERNovember 29, 1982
K813077techniconTECHNICON RA 1000 SYSTEMNovember 16, 1981
K811249technicon instrumentsTECHNICON SMAC II SYSTEM & ACCESSORIESMay 21, 1981
K810394sherman boosalisPRE-VAP CAPSMarch 6, 1981
K801481boehringer mannheimBMC RIAFLO SYSTEMAugust 20, 1980
K800587nobel scientific industriesNSI WASH SOLUTION CONCENTRATEAugust 8, 1980