510(k) K864819
- Device
- RAICHEM (TM)SERUM IRON AND TIBC REAGENTS
- Applicant
- REAGENTS APPLICATIONS, INC.
- 510(k) number
- K864819
- Product code
- JIY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-12
- Date received
- 1986-12-09
- Regulation
- 862.1410
- Classification name
- Photometric Method, Iron (non-heme)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- E.PEACOCK, JR
- Address
- 8225 Mercury Ct. San Diego CA US 92111 92111
FDA Registration Numbers#
- 3005094123
- 8020316
- 3006198300
- 1063851
- 3003795116
- 1181121
- 9680746
- 2050012
- 3005333358
- 2432235
- 9610529
- 1319809
- 3012963943
- 2250051
- 1832216
- 8040374
- 3002809144
- 2517506
- 2247288
- 3007662974
- 1827821
- 3011989923
- 3004493545
- 3002642396
- 2050010
- 2085064
- 9681753
- 1616487
- 9610126
- 1220972
- 1319681
- 3000308930
- 3006716639
- 3000148879
- 3004192065
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JIY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061793 | DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR | Dade Behring, Inc. | 2006-08-07 |
| K060264 | DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) | Dade Behring, Inc. | 2006-03-08 |
| K051115 | SENTINEL IRON LIQUID | Sentinel Ch. Srl | 2005-08-25 |
| K033983 | VITALAB IRON REAGENT | Clinical Data, Inc. | 2004-05-21 |
| K030528 | ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) | Clinical Data | 2003-06-17 |
| K020816 | IRON-PC-SL ASSAY MODEL # 151-10, 151-26 | Diagnostic Chemicals , Ltd. | 2002-05-14 |
| K013097 | WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 | Wiener Laboratories Saic | 2001-11-13 |
| K981241 | IRON | Abbott Laboratories | 1998-05-01 |
| K973933 | SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| K972363 | IL TEST IRON | Instrumentation Laboratory CO | 1997-08-15 |
| K964913 | IRON REAGENT | Derma Media Lab., Inc. | 1997-02-20 |
| K961588 | TOTAL IRON (NITRO-PAPS) REAGENT SET | Pointe Scientific, Inc., | 1996-11-18 |
| K935712 | IRON/TIBC REAGENT | Horizon Diagnostics, Inc. | 1995-09-20 |
| K944911 | ACE IRON REAGENT | Schiapparelli Biosystems, Inc. | 1995-02-10 |
| K943029 | IRON QVET | Prisma Systems | 1994-12-02 |
Legacy Summary#
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FDA Review#
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