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JJS — Controls For Blood-Gases, (Assayed And Unassayed) Class I

FDA Device Classification

Classification Details

Product Code
JJS
Device Class
Class I
Regulation Number
862.1660
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K152553eurotrolCueSee HypoxicApril 22, 2016
K150226radiometer medical apsHematocrit and Metabolite QUALICHECKMay 13, 2015
K130415radiometer medical apsHIGH METABOLITE QUALICHECKMarch 26, 2013
K130236radiometer medical apsRANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVELMarch 15, 2013
K033063diamond diagnosticsMISSION CONTROLSDecember 12, 2003
K022529bio-radLIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AAugust 15, 2002
K022525bio-radLIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2August 15, 2002
K003239bio-radLIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506November 30, 2000
K003242bio-radLIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623November 30, 2000
K002866bio-radLIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574September 25, 2000
K002865bio-radLIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578September 25, 2000
K002535bio-radLIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513August 30, 2000
K002536bio-radLIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)August 30, 2000
K002120bio-radLIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573August 21, 2000
K980135radiometer americaQUALICHECK5+ MODELS S7730, S7740, S7750, S7760January 28, 1998
K972861instrumentation laboratoryIL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)August 19, 1997
K961355radiometer americaMULTICHECKJune 14, 1996
K961354radiometer americaQUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)June 14, 1996
K961441instrumentariumTONOMETERED SLAINE BLOOD GAS CONTROLApril 30, 1996
K955340direct solutionsEUROTROL GAS - ISE CONTROLDecember 26, 1995