Atlas FDA

JIY

67 FDA 510(k) clearances · Product code

44 daysmedian time to decision
115 days90th percentile
67clearances measured

FDA profile

Official device name
Photometric Method, Iron (Non-Heme)
Device class
Class I (low risk)
Regulation
21 CFR 862.1410
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2012: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR (K061793)Dade Behring, Inc.2006-08-07
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) (K060264)Dade Behring, Inc.2006-03-08
SENTINEL IRON LIQUID (K051115)Sentinel Ch. Srl2005-08-25
VITALAB IRON REAGENT (K033983)Clinical Data, Inc.2004-05-21
ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (K030528)Clinical Data2003-06-17
IRON-PC-SL ASSAY MODEL # 151-10, 151-26 (K020816)Diagnostic Chemicals , Ltd.2002-05-14
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 (K013097)Wiener Laboratories Saic2001-11-13
IRON (K981241)Abbott Laboratories1998-05-01
SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 (K973933)Diagnostic Chemicals , Ltd.1997-11-04
IL TEST IRON (K972363)Instrumentation Laboratory CO1997-08-15
IRON REAGENT (K964913)Derma Media Lab., Inc.1997-02-20
TOTAL IRON (NITRO-PAPS) REAGENT SET (K961588)Pointe Scientific, Inc.,1996-11-18
IRON/TIBC REAGENT (K935712)Horizon Diagnostics, Inc.1995-09-20
ACE IRON REAGENT (K944911)Schiapparelli Biosystems, Inc.1995-02-10
IRON QVET (K943029)Prisma Systems1994-12-02
DMA IRON PROCEDURE (K944462)Data Medical Associates, Inc.1994-11-15
IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM (K935287)Miles, Inc.1994-01-03
IRON TEST (K935176)Em Diagnostic Systems, Inc.1993-12-16
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R (K930166)Em Diagnostic Systems, Inc.1993-04-21
OLYMPUS IRON REAGENT (K924691)Olympus Corp.1992-12-18
OLYMPUS IRON REAGENT (K923565)Olympus Corp.1992-09-28
THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II (K911170)Analytical Control Systems, Inc.1991-05-01
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE) (K910143)Eastman Kodak Company1991-02-04
TOTAL IRON FOR MANUAL/AUTOMATED (K902877)Catachem, Inc.1990-07-27
COULTER SERUM IRON/UIBC REAGENT (K902173)Coulter Corp.1990-06-12
IRON/TOTAL IRON BINDING CAPACITY (K901561)Tech-Co, Inc.1990-05-17
IRON LIQUID STABLE REAGENT (K900902)Medical Analysis Systems, Inc.1990-03-19
SYSTEMATE(TM) IRON ITEM NUMBER: 65417 (K895249)Em Diagnostic Systems, Inc.1989-10-31
IRON SYSTEM PACK REAGENTS (K892838)Boehringer Mannheim Corp.1989-06-16
EASY-TEST IRON (IRON) ITEM NO. 16686 (K892863)Em Diagnostic Systems, Inc.1989-06-07
KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT (K890573)Kenlor Industries, Inc.1989-03-24
BIOTROL IRON REAGENT (K890395)Biotrol, USA, Inc.1989-03-08
IRON REAGENTS ITEM NUMBER: SR1017 (K890304)Em Diagnostic Systems, Inc.1989-02-10
PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) (K890034)American Monitor Corp.1989-02-03
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE) (K884355)Eastman Kodak Company1988-12-16
TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS (K883792)Catachem, Inc.1988-10-12
PARAMAX IRON REAGENT (K881104)Baxter Healthcare Corp1988-04-28
IRON TEST (K881202)Sclavo, Inc.1988-04-28
IRON PROCEDURE (K881167)Data Medical Associates, Inc.1988-04-28
STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR (K880467)Stanbio Laboratory1988-03-24
IRON PROCEDURE (K874918)Data Medical Associates, Inc.1988-02-11
WAKO(TM) FE C (K874263)Wako Chemicals USA, Inc.1987-11-23
LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT (K870986)Beckman Instruments, Inc.1987-04-13
FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339 (K871284)American Research Products Co.1987-04-08
IRON(IRN) TESTPACK, ITEM NO. 67659/95 (K870144)Em Diagnostic Systems, Inc.1987-02-20
RAICHEM (TM)SERUM IRON AND TIBC REAGENTS (K864819)Reagents Applications, Inc.1987-02-12
FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY (K864882)Pointe Scientific, Inc.,1987-01-21
FERROFAST (K863109)J. D. Assoc.1986-11-24
IRON PROCEDURE (K863266)Data Medical Associates, Inc.1986-09-11
IRON PROCEDURE (K861652)Data Medical Associates, Inc.1986-05-29
ANALYTE IRON/TECHNICON CHEM 1 SYSTEM (K860799)Technicon Instruments Corp.1986-04-03
SERUM IRON & IRON BINDING REAGENT SET (K860478)Sterling Diagnostics, Inc.1986-03-14
SERUM IRON/VIBC REAGENT SET (K852161)Livonia Diagnostics, Inc.1985-06-10
SANDARE IRON PROCEDURE (K851394)Sandare Chemical Co., Inc.1985-04-30
SYSTE MATE IRON, HEM NO. 67224 (K845020)Em Diagnostic Systems, Inc.1985-01-28
TECHNICON RA-1000 SYS IRON FOR SERUM (K843255)Technicon Instruments Corp.1984-09-14
PARAMAX IRON BLANK REAGENT (K841887)American Dade1984-06-22
PARAMAX IRON REAGENT (K841886)American Dade1984-06-22
SERUM IRON & TIBC#65084 & 65085 (K833017)Emd Chemicals, Inc.1983-11-03
SERUM IRON-PTF-600 (K831201)American Monitor Corp.1983-05-25
SPIN CHEM REAGENTS & STANDARDS (K821184)Smithkline Diagnostics, Inc.1982-05-24
SERUM IRON REAGENT SET (K812840)Anco Medical Reagents & Assoc.1981-12-03
DIRECT IRON REAGENT SET (K812777)The Dow Chemical Co.1981-10-19
REAGENTS FOR DETERM. SERUM IRON IN HUMAN (K800677)Diagnostic Solutions, Inc.1980-05-28
TOTAL IRON IN SERUM (K782160)Fisher Scientific Co., LLC1979-01-26
IRON BINDING CAPICITY MODEL 0370 (K781865)Stanbio Laboratory1978-12-04
SERUM IRON (K771838)Gamma Enterprises, Inc.1977-11-03

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