Atlas FDA

JJT

97 FDA 510(k) clearances · Product code

32 daysmedian time to decision
88 days90th percentile
97clearances measured

FDA profile

Official device name
Enzyme Controls (Assayed And Unassayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
1998: 1 · 2001: 5 · 2003: 4 · 2004: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED (K090940)Astoria-Pacific, Inc.2009-12-14
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER (K062751)Quantimetrix Corp.2006-10-03
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL (K030768)Cliniqa Corporation2003-03-21
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 (K030102)Bayer Healthcare, LLC2003-01-24
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL (K021498)Bio-Rad2002-05-24
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 (K012656)Bio-Rad2001-09-06
CARDIASURE CARDIAC MARKERS CONTROL (K993723)Quantimetrix Corp.1999-11-23
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (K993715)Seracare Technology1999-11-16
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (K992430)Medical Analysis Systems, Inc.1999-08-30
QUANTEX ASO-CRP-RP CONTROL II (K984437)Instrumentation Laboratory CO1999-02-02
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (K984277)Medical Analysis Systems, Inc.1998-12-09
CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 (K982845)More Diagnostics1998-08-21
LIQUICHEK CARDIAC MARKERS CONTROL LT (K980556)Bio-Rad1998-02-25
TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL (K974461)Biosite Incorporated1997-12-10
DADE TRU-LIQUID CARDIAC CONTROL (K973974)Dade Intl., Inc.1997-11-06
CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL (K972976)More Diagnostics1997-08-29
CARDIAC STATUS CONTROLS (K972408)Spectral Diagnostics, Inc.1997-07-25
QUANTEX ASO-CRP-RF CONTROL (K971777)Instrumentation Laboratory CO1997-05-27
CARDIOISOZYME, CK/LD ISOENZYME CONTROL (K970856)Medical Analysis Systems, Inc.1997-04-08
STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003) (K965169)Specialized Assays, Inc.1997-02-06
STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) (K965166)Specialized Assays, Inc.1997-02-04
STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) (K965168)Specialized Assays, Inc.1997-02-04
LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) (K961828)Bio-Rad1996-06-11
OPUS CK-MB & TOTAL CK CONTROLS (K960275)Behring Diagnostics, Inc.1996-04-25
LIQUID CARDIAC MARKER 1,2,3 ASSAYED (K960246)Ciba Corning Diagnostics Corp.1996-04-23
ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE (K950803)Isolab, Inc.1995-09-21
QUANTITATE ENZYME VERIFIER SET (K951293)Beckman Instruments, Inc.1995-04-20
CARDIO REP LD CONTROL - CAT NO. 3325 (K950801)Helena Laboratories1995-03-30
CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION (K946146)Clinical Controls, Inc.1995-01-24
CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL (K946145)Clinical Controls, Inc.1995-01-24
CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, (K944923)Clinical Controls, Inc.1994-11-04
CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL (K944247)Cala Diagnostics1994-10-31
CARDIOCHEX CKMB MASS MEASUREMENT CONTROL (K944246)Cala Diagnostics1994-10-31
CARDIOCHEX (K944243)Cala Diagnostics1994-10-27
HICHEM ENZYME VERIFIER KIT (K943684)Hi Chem, Inc.1994-10-04
CARDIO REP RECOMBINANT CK ABNORMAL CONTROL (K932442)Helena Laboratories1993-10-28
ROCHE CARDIOTROL-CK (K930889)Roche Diagnostic Systems, Inc.1993-07-06
CKMB ISOENZYME CONTROL-LEVEL 1,2.3 (K930873)Cala Diagnostics1993-04-13
CKMB CONTROL - LEVEL 1,2,3 (K930875)Cala Diagnostics1993-04-13
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3 (K925151)Bio-Rad1992-12-17
CK-MB IMMUNOASSAY CONTROL (K905623)Seradyn, Inc.1991-02-22
LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 (K903430)Bio-Rad1990-08-23
HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) (K902321)Hichem Diagnostics1990-06-28
CLP CK/LD ISOENZYME/IMMUNO CONTROL (K896465)Creative Laboratory Products, Inc.1990-03-01
CLP CK/LD ISOENZYME CONTROL (K894554)Creative Laboratory Products, Inc.1989-10-16
CK-MB/LD-1 CONTROL SYSTEM (K894207)Boehringer Mannheim Corp.1989-08-28
ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY (K883395)Quantimetrix Medical Industries1988-09-19
DADE(R) CK-MB IMMUNOASSAY CONTROL (K882795)Baxter Healthcare Corp1988-08-29
QUANTIMETRIX SERUM ENZYME CONTROL (K880701)Quantimetrix Corp.1988-03-24
MULTI-ENZYME LINEARITY SOLUTION (K880266)Verichem Laboratories, Inc.1988-02-18
QUANTIMETRIX TOTAL CREATINE KINASE CONTROL (K874302)Quantimetrix Medical Industries1988-02-02
TITAN GEL REP CPK/LDH ISOENZYME CONTROL (K874141)Helena Laboratories1987-11-04
VIRON(TM) (K872646)bioMerieux, Inc.1987-09-14
U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL (K870737)U. S. Diagnostics, Inc.1987-04-13
U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL (K870738)U. S. Diagnostics, Inc.1987-04-13
DOCUMENT ENZYME LINEARITY TEST SETS (K861506)Casco Standards1986-06-13
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 (K861512)Em Diagnostic Systems, Inc.1986-05-23
ISOTRAK AMYLASE ISOENZYME CONTROL SET (K861329)Behring Diagnostics, Inc.1986-04-30
EMDS ENZYME VERIFIER, LEVELS I & II (K860764)Em Diagnostic Systems, Inc.1986-04-07
CANTROL CK/MB CONTROL (K855006)Canyon Diagnostics, Inc.1986-01-17
V-TREND OC CPK (K854973)V-Tech, Inc.1986-01-13
DELTA TROL I & II (K853373)Electro-Nucleonics Laboratories, Inc.1985-08-23
CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ (K850907)Cala Diagnostics1985-06-25
CK/LD ISOENZYMES CONTROLS(HUMAN) (K851520)Seragen Diagnostics, Inc.1985-06-25
ISOCONTROL SERUM CK-MB (K850213)Sclavo, Inc.1985-03-05
ISOCONTROL SERUM LD- (K850211)Sclavo, Inc.1985-02-07
ID ZONE NORMAL LD ISOENZYME CONTROL (K843266)Beckman Instruments, Inc.1984-09-13
ID ZINE LD ISOENZYME CONTROL ABNORM (K843265)Beckman Instruments, Inc.1984-09-13
CK/MB IMMUNO-ISOENZYME CONTROL SERUM (K840793)Seragen Diagnostics, Inc.1984-04-13
ID-ZONE LD ISOENZYME CONTROL (K822984)Beckman Instruments, Inc.1982-11-10
QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM (K822646)Beckman Instruments, Inc.1982-09-30
TITAN GEL CPK/LDH ISOENZYME CONTROL (K821981)Helena Laboratories1982-07-22
TARGET ISOCHECK CONTROL SERUM (K821183)Smithkline Diagnostics, Inc.1982-05-14
AALTO LDH ISOENZYME CONTROL SERUM (K820360)Aalto Scientific, Ltd.1982-03-04
EMBRITROL CK-MB CONTROLS (K812671)Intl. Immunoassay Laboratories, Inc.1981-10-02
GEMENI CK-MB ISOENZYME ABNORMAL SERUM (K810870)Gemini, Inc.1981-04-14
QUALITROL #65057 (K810725)Harleco1981-03-31
DUPONT 'ACA' CREATINE KINASE VERIFIERS (K803305)E.I. Dupont DE Nemours & Co., Inc.1981-01-16
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D (K800604)Beckman Instruments, Inc.1980-04-10
QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) (K791723)Organon, Inc.1979-10-01
CPK ISOENZYME CONTROL (K791299)Electrophoresis Corp. of America1979-08-16
LDH ISOENZYME CONTROL (K791300)Electrophoresis Corp. of America1979-08-16
P.A.P. RIA CONTROL SERUM PACK (K790985)Mallinckrodt Critical Care1979-07-17
DELTA TEST AMYLASE/LIPASE CONTS. I,II (K781100)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-08-14
ISOZYME - ID CPK MARKER (K780801)Dade, Baxter Travenol Diagnostics, Inc.1978-06-13
CLIN. CHEM. CONTROL SERUM-QUANTITATE (K780554)Beckman Instruments, Inc.1978-06-06
CHEMISTRY CONTROL & REFERENCE SERUMS (K780204)Hyland Therapeutic Div., Travenol Laboratories1978-03-03
ISOENZYME SERUM CONTROL (K780147)Corning Medical & Scientific1978-02-23
ACA GLUTAMYL TRANSFERASE (K771800)E.I. Dupont DE Nemours & Co., Inc.1977-10-25
CARDIOZYME CK-CONTROL LEVEL 1 (K771740)Dade, Baxter Travenol Diagnostics, Inc.1977-10-19
SERONORM (K771436)Nyegaard & Co. A/S1977-09-02
AUTONORM (K771438)Nyegaard & Co. A/S1977-09-02
PATHONORM H & L (K771439)Nyegaard & Co. A/S1977-09-02
CARDIOZYME CK CONTROL NORMAL (K770973)Dade, Baxter Travenol Diagnostics, Inc.1977-08-04
CARDIOZYME CK-CONTROL ABNORMAL (K770971)Dade, Baxter Travenol Diagnostics, Inc.1977-08-04
CPK ISOENZYME CONTROL (K770555)Bio-Reagents & Diagnostics, Inc.1977-06-03
LDH ISOTROL T (K770049)Sigma Chemical Co.1977-01-26

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