510(k) K113438
- Device
- ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
- Applicant
- ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
- 510(k) number
- K113438
- Product code
- JMO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-06-01
- Date received
- 2011-11-21
- Regulation
- 862.1415
- Classification name
- Ferrozine (colorimetric) Iron Binding Capacity
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HYMAN KATZ
- Address
- 4 Henderson Dr. West Caldwell NJ US 07006 07006
FDA Registration Numbers#
- 8040374
- 8020316
- 3006716639
- 3010939897
- 2030861
- 2517506
- 1000403749
- 3006198300
- 3013660430
- 3004493545
- 3011989923
- 9680746
- 3000308930
- 1319808
- 3010825766
- 3002642396
- 3003593973
- 9610126
- 3003795116
- 1181121
- 2084025
- 3012963943
- 1832216
- 3021841051
- 1827821
- 2250051
- 2247288
- 2050012
- 9610529
- 3014325803
- 2050010
- 3003741796
- 2432235
- 1319681
Source Documents#
Other 510(k) Records For Product Code JMO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061464 | VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 | Ortho-Clinical Diagnostics, Inc. | 2006-06-15 |
| K052867 | VITROS CHEMISTRY PRODUCTS DTIBC REAGENT | Ortho-Clinical Diagnostics, Inc. | 2005-12-23 |
| K041793 | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 | Olympus America, Inc. | 2004-07-16 |
| K013102 | WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 | Wiener Laboratories Saic | 2001-11-13 |
| K012340 | BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) | Bayer Corp. | 2001-10-01 |
| K000781 | DIRECT TIBC KIT | Reference Diagnostics, Inc. | 2000-05-02 |
| K994115 | TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2000-01-28 |
| K991666 | TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 | A.P. Total Care, Inc. | 1999-06-30 |
| K991244 | TOTAL IRON, MODELS FE 109-01, FE 109-02 | A.P. Total Care, Inc. | 1999-05-25 |
| K990216 | MAGNETIC TIBC KIT | Reference Diagnostics, Inc. | 1999-02-16 |
| K982041 | UIBC | Abbott Laboratories | 1998-07-30 |
| K981654 | TIBC | Abbott Laboratories | 1998-07-22 |
| K981279 | TIBC | Abbott Laboratories | 1998-05-20 |
| K974604 | RANDOX IRON | Randox Laboratories, Ltd. | 1998-01-06 |
| K961587 | IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 | Diagnostic Chemicals , Ltd. | 1996-08-27 |
Legacy Summary#
summary
FDA Review#
Decision Summary