Product Code: JJS FDA class 1 21 CFR 862.1660

Controls For Blood-Gases, (Assayed And Unassayed)

Clinical Chemistry

This device consists of assayed and unassayed controls for blood gas measurements, used in clinical laboratories to monitor the performance of blood gas analyzers measuring parameters such as pH, partial pressure of oxygen and carbon dioxide, and bicarbonate. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without a premarket submission. The product code is JJS, regulated under 21 CFR 862.1660, and assigned to the Clinical Chemistry medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: JJS
Device Class: FDA class 1
Regulation Number: 862.1660
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 67 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K152553	CueSee Hypoxic	Apr 22, 2016	Substantially Equivalent	EUROTROL B.V.
K150226	Hematocrit and Metabolite QUALICHECK	May 13, 2015	Substantially Equivalent	RADIOMETER MEDICAL APS
K130415	HIGH METABOLITE QUALICHECK	Mar 26, 2013	Substantially Equivalent	RADIOMETER MEDICAL APS
K130236	RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3	Mar 15, 2013	Substantially Equivalent	RADIOMETER MEDICAL APS
K033063	MISSION CONTROLS	Dec 12, 2003	Substantially Equivalent	DIAMOND DIAGNOSTICS, INC.
K022529	LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669	Aug 15, 2002	Substantially Equivalent	BIO-RAD
K022525	LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509	Aug 15, 2002	Substantially Equivalent	BIO-RAD
K003242	LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623	Nov 30, 2000	Substantially Equivalent	BIO-RAD
K003239	LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506	Nov 30, 2000	Substantially Equivalent	BIO-RAD
K002866	LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574	Sep 25, 2000	Substantially Equivalent	BIO-RAD
K002865	LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578	Sep 25, 2000	Substantially Equivalent	BIO-RAD
K002536	LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)	Aug 30, 2000	Substantially Equivalent	BIO-RAD
K002535	LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513	Aug 30, 2000	Substantially Equivalent	BIO-RAD
K002120	LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573	Aug 21, 2000	Substantially Equivalent	BIO-RAD
K980135	QUALICHECK5+ MODELS S7730, S7740, S7750, S7760	Jan 28, 1998	Substantially Equivalent	RADIOMETER AMERICA, INC.
K972861	IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)	Aug 19, 1997	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K961355	MULTICHECK	Jun 14, 1996	Substantially Equivalent	RADIOMETER AMERICA, INC.
K961354	QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)	Jun 14, 1996	Substantially Equivalent	RADIOMETER AMERICA, INC.
K961441	TONOMETERED SLAINE BLOOD GAS CONTROL	Apr 30, 1996	Substantially Equivalent	INSTRUMENTARIUM CORP.
K955340	EUROTROL GAS - ISE CONTROL	Dec 26, 1995	Substantially Equivalent	DIRECT SOLUTIONS
K952637	QUALICHECK 4 GLUCOSE	Sep 05, 1995	Substantially Equivalent	RADIOMETER AMERICA, INC.
K952477	STAT PROFILE ULTRA BLOOD GAS CONTROLS	Jul 06, 1995	Substantially Equivalent	NOVA BIOMEDICAL CORP.
K950902	ALKO TONOMETERED SALINE CONTROL	Mar 30, 1995	Substantially Equivalent	ALKO DIAGNOSTIC CORP.
K946224	CERTAIN(R) ELITE LEVEL 1, 2 AND 3	Jan 30, 1995	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K945860	SPECTRUM CO-OXIMETER LINEARITY CONTROL	Jan 17, 1995	Substantially Equivalent	PHOENIX DIAGNOSTICS, INC.
K935515	MULTICHECK(TM)	Apr 26, 1994	Substantially Equivalent	RADIOMETER AMERICA, INC.
K923342	MICROBACT SOLID PLATE SYSTEMS	Sep 22, 1992	Substantially Equivalent	RADIOMETER AMERICA, INC.
K920285	BLOOD GAS/ISE LINEARITY CONTROL	Jul 14, 1992	Substantially Equivalent	PHOENIX DIAGNOSTICS, INC.
K922357	RNA MEDICAL'S EQUIL 55	Jun 30, 1992	Substantially Equivalent	BIONOSTICS, INC.
K915399	QUALICHECK 4	Jan 02, 1992	Substantially Equivalent	RADIOMETER AMERICA, INC.
K904733	QUALICHECK 3	Nov 02, 1990	Substantially Equivalent	RADIOMETER AMERICA, INC.
K901985	BLOOD GAS CONTROLS	Jun 06, 1990	Substantially Equivalent	PHOENIX DIAGNOSTICS, INC.
K901986	CO-OXIMETER CONTROLS	May 31, 1990	Substantially Equivalent	PHOENIX DIAGNOSTICS, INC.
K901976	BLOOD GAS/CO-OXIMETRY CONTROL	May 31, 1990	Substantially Equivalent	PHOENIX DIAGNOSTICS, INC.
K894110	QUALICHECK 2	Aug 03, 1989	Substantially Equivalent	RADIOMETER AMERICA, INC.
K874408	MULTI-FUNCTION BLOOD GAS CONTROL	Dec 14, 1987	Substantially Equivalent	BIONOSTICS, INC.
K872196	AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III	Jul 31, 1987	Substantially Equivalent	AMERICAN DADE
K870036	BAYER HEALTHCARE RAPIDQC PLUS	Jan 14, 1987	Substantially Equivalent	CIBA CORNING DIAGNOSTICS CORP.
K855024	MARQUEST QC-IV TONOMETER	Apr 07, 1986	Substantially Equivalent	MARQUEST MEDICAL PRODUCTS, INC.
K851911	MULTI FUNCTION BLOOD GAS CONTROL	May 20, 1985	Substantially Equivalent	BIONOSTICS, INC.
K841783	BLOOD GAS CONTROL, LEVEL I(ACIDOSIS	Jun 14, 1984	Substantially Equivalent	BIONOSTICS, INC.
K833146	AQUEOUS BLOOD GAS CONTROL	Nov 28, 1983	Substantially Equivalent	BIONOSTICS, INC.
K832003	AQUEOUS BLOOD GAS CONTROL LEVEL I,II &	Aug 10, 1983	Substantially Equivalent	AMERICAN DADE
K832028	CERTAIN HB CO-OXIMETER CONTROL	Jul 18, 1983	Substantially Equivalent	CORNING MEDICAL & SCIENTIFIC
K830181	REFEREE BLOOD GAS ANALYZER CONTROLS	Feb 28, 1983	Substantially Equivalent	ANALYTICAL PRODUCTS, INC.
K820873	CORNING CERTAIN TM	Apr 16, 1982	Substantially Equivalent	CORNING MEDICAL & SCIENTIFIC
K820705	GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL	Apr 01, 1982	Substantially Equivalent	UNITED DIAGNOSTICS, INC.
K820319	FETAL-TEK CONTROL MATURE	Mar 25, 1982	Substantially Equivalent	HELENA LABORATORIES
K820103	PATHWAY PH BLOOD GAS CONTROL	Jan 28, 1982	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K812601	SQC BUFFER	Oct 02, 1981	Substantially Equivalent	TRANSIDYNE GENERAL CORP.
K812553	AQUEOUS BLOOD GAS CONTROLS	Sep 23, 1981	Substantially Equivalent	FISHER SCIENTIFIC CO., LLC.
K812541	PROTEIN-BASED BLOOD GAS CONTROL	Sep 23, 1981	Substantially Equivalent	AMERICAN DADE
K811143	PH/BLOOD GAS CONTROL (ABC)	May 13, 1981	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K810107	RESPA-TROL	Jan 26, 1981	Substantially Equivalent	INTENSIVE TECHNOLOGY, INC.
K801449	BLOOD GAS CONTROL PROD. NO. BG-1, BG-2	Jul 21, 1980	Substantially Equivalent	HEALTH DIAGNOSTICS CORP.
K792447	REFEREE BFT BLOOD FOR TONOMETRY	Dec 27, 1979	Substantially Equivalent	ANALYTICAL PRODUCTS, INC.
K792180	CORNING CONFIRM BLOOD GAS QUALITY CONTRO	Nov 13, 1979	Substantially Equivalent	CORNING MEDICAL & SCIENTIFIC
K792143	FISHER DIAG. PRIME BLOOD GAS CONTROLS	Nov 13, 1979	Substantially Equivalent	FISHER SCIENTIFIC CO., LLC.
K792098	GAS-TRAK BLOOD GAS CONTROL	Nov 13, 1979	Substantially Equivalent	UNITED DIAGNOSTICS, INC.
K791287	MEDICOR QUALITY CONTROL BUFFER	Aug 16, 1979	Substantially Equivalent	MEDICOR USA LTD.
K790813	MULTECON BLOOD GAS CONTROL	Jun 28, 1979	Substantially Equivalent	ORTHO DIAGNOSTICS, INC.
K781421	BIOSCAN E12	Sep 20, 1978	Substantially Equivalent	CLINIFAX INDUSTRIES, LTD.
K780144	DYNEX BLOOD GAS QUALITY CONTROL SYS.	May 26, 1978	Substantially Equivalent	ANALYTICAL PRODUCTS, INC.
K771444	QUALICHECK TM	Aug 16, 1977	Substantially Equivalent	THE LONDON CO.
K770950	WHOLE BLOOD GAS CONTROL	Aug 02, 1977	Substantially Equivalent	DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771044	TMA BICARBONATE DILUENT	Jul 15, 1977	Substantially Equivalent	HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K770228	AQUEOUS PH/BLOOD GAS CONTROLS	Jun 27, 1977	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.

FEI Numbers

This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

1219029: 104 registrations

1220649: 82 registrations

1222035: 12 registrations

1827821: 149 registrations

2016706: 124 registrations

2432235: 462 registrations

3002637618: 60 registrations

3002806557: 53 registrations

3002807968: 18 registrations

3003030793: 34 registrations

3003971136: 58 registrations

3004493545: 205 registrations

3005333358: 273 registrations

3005695774: 16 registrations

3006198300: 142 registrations

3010127294: 125 registrations

3011325031: 7 registrations

3013513377: 17 registrations

3023162659: 45 registrations