TINA-QUANT(R) IGA
FDA 510(k) clearance K862763 · decided 1986-09-04
Clearance details
- K-number
- K862763
- Device name
- TINA-QUANT(R) IGA
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-22
- Decision date
- 1986-09-04
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- CZP
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (K193525) | HORIBA ABX SAS | 2020-06-26 |
| IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT (K060130) | Beckman Coulter, Inc. | 2006-02-13 |
| ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 (K040435) | Roche Diagnostics Corp. | 2004-03-10 |
| N LATEX IGA (K024038) | Dade Behring, Inc. | 2003-02-13 |
| WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD (K993927) | Wako Chemicals USA, Inc. | 2000-01-14 |
| IGA (K983359) | Abbott Laboratories | 1998-11-04 |
| QUANTEX IGA (K962200) | Instrumentation Laboratory CO | 1996-09-25 |
| IGA IMMUNOTURBIDIMETRIC & CALIBRATOR (K955794) | Randox Laboratories, Ltd. | 1996-04-05 |
| BOEHRINGER MANNHEIM IGA ASSAY (K955907) | Boehringer Mannheim Corp. | 1996-02-09 |
| N LATEX IGA (K952309) | Behring Diagnostics, Inc. | 1995-06-20 |
| IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE (K931806) | The Binding Site, Ltd. | 1993-07-16 |
| IL TEST IMMUNOGLOBULIN A (K920014) | Instrumentation Laboratory CO | 1992-06-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |