BOEHRINGER MANNHEIM IGG ASSAY
FDA 510(k) clearance K955906 · decided 1996-02-09
Clearance details
- K-number
- K955906
- Device name
- BOEHRINGER MANNHEIM IGG ASSAY
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-29
- Decision date
- 1996-02-09
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- DFZ
- 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 |
|---|---|---|
| DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG (K092283) | Siemens Healthcare Diagnostics | 2009-10-21 |
| HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER (K021081) | The Binding Site, Ltd. | 2002-06-17 |
| PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT (K020823) | Sanquin Blood Supply Foundation | 2002-05-14 |
| IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER (K940422) | The Binding Site, Ltd. | 1994-05-27 |
| H-103 IGG, H-104 IGA, H-105 IGM (K812821) | Immulok, Inc. | 1981-10-26 |
| AUTOMATED IMMUNOPRECIPITIN METHOD/ICG (K803272) | Icl Scientific | 1981-01-26 |
| ANTISERA TO RABBIT IMMUNOGLOBULIN (K790720) | Kent Laboratories, Inc. | 1979-08-16 |
| ANTISERUM TO RABBIT IMMUNOGLOBULIN (K790709) | Kent Laboratories, Inc. | 1979-08-16 |
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 |