CZP — Iga, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- CZP
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K193525 | horiba abx | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Im | June 26, 2020 |
| K060130 | beckman coulter | IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT | February 13, 2006 |
| K040435 | roche diagnostics | ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 | March 10, 2004 |
| K024038 | dade behring | N LATEX IGA | February 13, 2003 |
| K993927 | wako chemicals usa | WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD | January 14, 2000 |
| K983359 | abbott laboratories | IGA | November 4, 1998 |
| K962200 | instrumentation laboratory | QUANTEX IGA | September 25, 1996 |
| K955794 | randox laboratories | IGA IMMUNOTURBIDIMETRIC & CALIBRATOR | April 5, 1996 |
| K955907 | boehringer mannheim | BOEHRINGER MANNHEIM IGA ASSAY | February 9, 1996 |
| K952309 | behring diagnostics | N LATEX IGA | June 20, 1995 |
| K931806 | binding site | IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE | July 16, 1993 |
| K920014 | instrumentation laboratory | IL TEST IMMUNOGLOBULIN A | June 16, 1992 |
| K900422 | helena laboratories | TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 | February 27, 1990 |
| K894418 | reagents applications | RAICHEM(TM) SPIA(TM) IGA REAGENTS | August 2, 1989 |
| K890560 | atlantic antibodies | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | February 15, 1989 |
| K884040 | orion diagnostica | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | October 19, 1988 |
| K883492 | technicon instruments | TECHNICON DPA-1 IMMUNOGLOBULIN A | September 22, 1988 |
| K880803 | wako chemicals usa | WAKO(TM) IGA-HA DIRECT | March 29, 1988 |
| K873869 | unipath | IMMUNOGLOBULINS A | October 13, 1987 |
| K871940 | kallestad diag, a div. of erbamont | QM300 IGA, ANTIGEN, ANTISERUM, CONTROL | June 12, 1987 |