Boehringer Mannheim Igg Assay
FDA 510(k) K955906 · Boehringer Mannheim Corp.
510(k) numberK955906
Submission
- Device name
- Boehringer Mannheim Igg Assay
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- December 29, 1995
- Decision date
- February 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DFZ – Igg (Gamma Chain Specific), Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DFZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092283 | Dimension Vista Immunoglobulin Igg Subclasss 1FLEX Reagent Cartridge, Dimension Vista…DFZ · Traditional | Siemens Healthcare Diagnostics | 10/21/2009SE |
| K021081 | Human Igg Subclass Liquid Reagent Kits for Use on the Hitachi 911/7070 Turbidimetric…DFZ · Traditional | The Binding Site, Ltd. | 06/17/2002SE |
| K020823 | Peliclass Human Igg Subclass Nephelometric Immage KitDFZ · Traditional | Sanquin Blood Supply Foundation | 05/14/2002SE |
| K940422 | Igg Subclass Single Dilution Diagnostic Kit for Use with the Beckman Array AnalyzerDFZ · Traditional | The Binding Site, Ltd. | 05/27/1994SE |
| K812821 | H-103 Igg, H-104 Iga, H-105 IgmDFZ · Traditional | Immulok, Inc. | 10/26/1981SE |
| K803272 | Automated Immunoprecipitin Method/IcgDFZ · Traditional | Icl Scientific | 01/26/1981SE |
| K790720 | Antisera to Rabbit ImmunoglobulinDFZ · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |
| K790709 | Antiserum to Rabbit ImmunoglobulinDFZ · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |
More from Kent Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Boehringer Mannheim Igg Assay cleared by the FDA?
Boehringer Mannheim Igg Assay (K955906) received a 510(k) decision of Substantially Equivalent on February 9, 1996, 42 days after the submission was received.
What is the product code of K955906?
The FDA product code is DFZ – Igg (Gamma Chain Specific), Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.