FDA Product Code
FDA Product Code JIY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1410
510(k) Clearances — 67 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K061793 | DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR | Dade Behring, Inc. | 2006-08-07 | Special | PDF ↗ |
| K060264 | DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) | Dade Behring, Inc. | 2006-03-08 | Traditional | PDF ↗ |
| K051115 | SENTINEL IRON LIQUID | Sentinel Ch. Srl | 2005-08-25 | Traditional | PDF ↗ |
| K033983 | VITALAB IRON REAGENT | Clinical Data, Inc. | 2004-05-21 | Traditional | PDF ↗ |
| K030528 | ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) | Clinical Data | 2003-06-17 | Traditional | PDF ↗ |
| K020816 | IRON-PC-SL ASSAY MODEL # 151-10, 151-26 | Diagnostic Chemicals , Ltd. | 2002-05-14 | Traditional | PDF ↗ |
| K013097 | WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 | Wiener Laboratories Saic | 2001-11-13 | Traditional | PDF ↗ |
| K981241 | IRON | Abbott Laboratories | 1998-05-01 | Traditional | PDF ↗ |
| K973933 | SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 | Diagnostic Chemicals , Ltd. | 1997-11-04 | Traditional | PDF ↗ |
| K972363 | IL TEST IRON | Instrumentation Laboratory CO | 1997-08-15 | Traditional | PDF ↗ |
| K964913 | IRON REAGENT | Derma Media Lab., Inc. | 1997-02-20 | Traditional | PDF ↗ |
| K961588 | TOTAL IRON (NITRO-PAPS) REAGENT SET | Pointe Scientific, Inc., | 1996-11-18 | Traditional | PDF ↗ |
| K935712 | IRON/TIBC REAGENT | Horizon Diagnostics, Inc. | 1995-09-20 | Traditional | PDF ↗ |
| K944911 | ACE IRON REAGENT | Schiapparelli Biosystems, Inc. | 1995-02-10 | Traditional | PDF ↗ |
| K943029 | IRON QVET | Prisma Systems | 1994-12-02 | Traditional | PDF ↗ |
| K944462 | DMA IRON PROCEDURE | Data Medical Associates, Inc. | 1994-11-15 | Traditional | PDF ↗ |
| K935287 | IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM | Miles, Inc. | 1994-01-03 | Traditional | PDF ↗ |
| K935176 | IRON TEST | Em Diagnostic Systems, Inc. | 1993-12-16 | Traditional | PDF ↗ |
| K930166 | IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R | Em Diagnostic Systems, Inc. | 1993-04-21 | Traditional | PDF ↗ |
| K924691 | OLYMPUS IRON REAGENT | Olympus Corp. | 1992-12-18 | Traditional | PDF ↗ |
| K923565 | OLYMPUS IRON REAGENT | Olympus Corp. | 1992-09-28 | Traditional | PDF ↗ |
| K911170 | THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II | Analytical Control Systems, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K910143 | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE) | Eastman Kodak Company | 1991-02-04 | Traditional | PDF ↗ |
| K902877 | TOTAL IRON FOR MANUAL/AUTOMATED | Catachem, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K902173 | COULTER SERUM IRON/UIBC REAGENT | Coulter Corp. | 1990-06-12 | Traditional | PDF ↗ |
| K901561 | IRON/TOTAL IRON BINDING CAPACITY | Tech-Co, Inc. | 1990-05-17 | Traditional | PDF ↗ |
| K900902 | IRON LIQUID STABLE REAGENT | Medical Analysis Systems, Inc. | 1990-03-19 | Traditional | PDF ↗ |
| K895249 | SYSTEMATE(TM) IRON ITEM NUMBER: 65417 | Em Diagnostic Systems, Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K892838 | IRON SYSTEM PACK REAGENTS | Boehringer Mannheim Corp. | 1989-06-16 | Traditional | PDF ↗ |
| K892863 | EASY-TEST IRON (IRON) ITEM NO. 16686 | Em Diagnostic Systems, Inc. | 1989-06-07 | Traditional | PDF ↗ |
| K890573 | KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT | Kenlor Industries, Inc. | 1989-03-24 | Traditional | PDF ↗ |
| K890395 | BIOTROL IRON REAGENT | Biotrol, USA, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K890304 | IRON REAGENTS ITEM NUMBER: SR1017 | Em Diagnostic Systems, Inc. | 1989-02-10 | Traditional | PDF ↗ |
| K890034 | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) | American Monitor Corp. | 1989-02-03 | Traditional | PDF ↗ |
| K884355 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE) | Eastman Kodak Company | 1988-12-16 | Traditional | PDF ↗ |
| K883792 | TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS | Catachem, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K881104 | PARAMAX IRON REAGENT | Baxter Healthcare Corp | 1988-04-28 | Traditional | PDF ↗ |
| K881202 | IRON TEST | Sclavo, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K881167 | IRON PROCEDURE | Data Medical Associates, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K880467 | STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR | Stanbio Laboratory | 1988-03-24 | Traditional | PDF ↗ |
| K874918 | IRON PROCEDURE | Data Medical Associates, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K874263 | WAKO(TM) FE C | Wako Chemicals USA, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K870986 | LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT | Beckman Instruments, Inc. | 1987-04-13 | Traditional | PDF ↗ |
| K871284 | FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339 | American Research Products Co. | 1987-04-08 | Traditional | PDF ↗ |
| K870144 | IRON(IRN) TESTPACK, ITEM NO. 67659/95 | Em Diagnostic Systems, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K864819 | RAICHEM (TM)SERUM IRON AND TIBC REAGENTS | Reagents Applications, Inc. | 1987-02-12 | Traditional | PDF ↗ |
| K864882 | FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY | Pointe Scientific, Inc., | 1987-01-21 | Traditional | PDF ↗ |
| K863109 | FERROFAST | J. D. Assoc. | 1986-11-24 | Traditional | PDF ↗ |
| K863266 | IRON PROCEDURE | Data Medical Associates, Inc. | 1986-09-11 | Traditional | PDF ↗ |
| K861652 | IRON PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K860799 | ANALYTE IRON/TECHNICON CHEM 1 SYSTEM | Technicon Instruments Corp. | 1986-04-03 | Traditional | PDF ↗ |
| K860478 | SERUM IRON & IRON BINDING REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-14 | Traditional | PDF ↗ |
| K852161 | SERUM IRON/VIBC REAGENT SET | Livonia Diagnostics, Inc. | 1985-06-10 | Traditional | PDF ↗ |
| K851394 | SANDARE IRON PROCEDURE | Sandare Chemical Co., Inc. | 1985-04-30 | Traditional | PDF ↗ |
| K845020 | SYSTE MATE IRON, HEM NO. 67224 | Em Diagnostic Systems, Inc. | 1985-01-28 | Traditional | PDF ↗ |
| K843255 | TECHNICON RA-1000 SYS IRON FOR SERUM | Technicon Instruments Corp. | 1984-09-14 | Traditional | PDF ↗ |
| K841886 | PARAMAX IRON REAGENT | American Dade | 1984-06-22 | Traditional | PDF ↗ |
| K841887 | PARAMAX IRON BLANK REAGENT | American Dade | 1984-06-22 | Traditional | PDF ↗ |
| K833017 | SERUM IRON & TIBC#65084 & 65085 | Emd Chemicals, Inc. | 1983-11-03 | Traditional | PDF ↗ |
| K831201 | SERUM IRON-PTF-600 | American Monitor Corp. | 1983-05-25 | Traditional | PDF ↗ |
| K821184 | SPIN CHEM REAGENTS & STANDARDS | Smithkline Diagnostics, Inc. | 1982-05-24 | Traditional | PDF ↗ |
| K812840 | SERUM IRON REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-03 | Traditional | PDF ↗ |
| K812777 | DIRECT IRON REAGENT SET | The Dow Chemical Co. | 1981-10-19 | Traditional | PDF ↗ |
| K800677 | REAGENTS FOR DETERM. SERUM IRON IN HUMAN | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K782160 | TOTAL IRON IN SERUM | Fisher Scientific Co., LLC | 1979-01-26 | Traditional | PDF ↗ |
| K781865 | IRON BINDING CAPICITY MODEL 0370 | Stanbio Laboratory | 1978-12-04 | Traditional | PDF ↗ |
| K771838 | SERUM IRON | Gamma Enterprises, Inc. | 1977-11-03 | Traditional | PDF ↗ |
Product code JIY · Class I · Clinical Chemistry. Data: openFDA.