510(k) K962200
- Device
- QUANTEX IGA
- Applicant
- INSTRUMENTATION LABORATORY CO.
- 510(k) number
- K962200
- Product code
- CZP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-25
- Date received
- 1996-06-07
- Regulation
- 866.5510
- Classification name
- Iga, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BETTY J LANE
- Address
- 113 Hartwell Ave. Lexington MA US 02173 02173
FDA Registration Numbers#
- 3005094123
- 3006198300
- 3003795116
- 3009189893
- 1181121
- 9610806
- 9610099
- 2050012
- 3005333358
- 9610529
- 3002809144
- 1000403749
- 3003423869
- 3013059683
- 3019906
- 3004493545
- 3016438761
- 2050010
- 9610126
- 3003601075
- 3000148879
Source Documents#
Other 510(k) Records For Product Code CZP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | HORIBA ABX SAS | 2020-06-26 |
| K060130 | IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT | Beckman Coulter, Inc. | 2006-02-13 |
| K040435 | ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 | Roche Diagnostics Corp. | 2004-03-10 |
| K024038 | N LATEX IGA | Dade Behring, Inc. | 2003-02-13 |
| K993927 | WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD | Wako Chemicals USA, Inc. | 2000-01-14 |
| K983359 | IGA | Abbott Laboratories | 1998-11-04 |
| K955794 | IGA IMMUNOTURBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | 1996-04-05 |
| K955907 | BOEHRINGER MANNHEIM IGA ASSAY | Boehringer Mannheim Corp. | 1996-02-09 |
| K952309 | N LATEX IGA | Behring Diagnostics, Inc. | 1995-06-20 |
| K931806 | IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | 1993-07-16 |
| K920014 | IL TEST IMMUNOGLOBULIN A | Instrumentation Laboratory CO | 1992-06-16 |
| K900422 | TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 | Helena Laboratories | 1990-02-27 |
| K894418 | RAICHEM(TM) SPIA(TM) IGA REAGENTS | Reagents Applications, Inc. | 1989-08-02 |
| K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | Atlantic Antibodies | 1989-02-15 |
| K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | Orion Diagnostica, Inc. | 1988-10-19 |
Legacy Summary#
summary
FDA Review#
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