JIY — Photometric Method, Iron (Non-Heme) Class I
FDA product code JIY covers "Photometric Method, Iron (Non-Heme)", a Class I medical device regulated under 21 CFR 862.1410. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JIY
- Device Class
- Class I
- Regulation Number
- 862.1410
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K061793 | dade behring | DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR | August 7, 2006 |
| K060264 | dade behring | DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) | March 8, 2006 |
| K051115 | sentinel ch | SENTINEL IRON LIQUID | August 25, 2005 |
| K033983 | clinical data | VITALAB IRON REAGENT | May 21, 2004 |
| K030528 | clinical data | ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) | June 17, 2003 |
| K020816 | diagnostic chemicals | IRON-PC-SL ASSAY MODEL # 151-10, 151-26 | May 14, 2002 |
| K013097 | wiener laboratories saic | WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 | November 13, 2001 |
| K981241 | abbott laboratories | IRON | May 1, 1998 |
| K973933 | diagnostic chemicals | SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 | November 4, 1997 |
| K972363 | instrumentation laboratory | IL TEST IRON | August 15, 1997 |
| K964913 | derma media lab | IRON REAGENT | February 20, 1997 |
| K961588 | pointe scientific, inc | TOTAL IRON (NITRO-PAPS) REAGENT SET | November 18, 1996 |
| K935712 | horizon diagnostics | IRON/TIBC REAGENT | September 20, 1995 |
| K944911 | schiapparelli biosystems | ACE IRON REAGENT | February 10, 1995 |
| K943029 | prisma systems | IRON QVET | December 2, 1994 |
| K944462 | data medical associates | DMA IRON PROCEDURE | November 15, 1994 |
| K935287 | miles | IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM | January 3, 1994 |
| K935176 | em diagnostic systems | IRON TEST | December 16, 1993 |
| K930166 | em diagnostic systems | IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R | April 21, 1993 |
| K924691 | olympus | OLYMPUS IRON REAGENT | December 18, 1992 |