CZP — Iga, Antigen, Antiserum, Control Class II
FDA product code CZP covers "Iga, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |