Elecys Ige Assay
FDA 510(k) K984326 · Boehringer Mannheim Corp.
510(k) numberK984326
Submission
- Device name
- Elecys Ige Assay
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- December 3, 1998
- Decision date
- February 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHR – Radioimmunoassay, Immunoglobulins (D, E)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code JHR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061970 | Elecsys Ige II ImmunoassayJHR · Special | Roche Diagnostics | 08/31/2006SE |
| K960067 | Immilite Total IgeJHR · Traditional | Diagnostic Products Corp. | 02/14/1996SE |
| K931703 | Immulite Total IgeJHR · Traditional | Diagnostic Products Corp. | 08/16/1993SE |
| K903000 | Turbo-Rast Specific Ige AssayJHR · Traditional | Ventrex Laboratories, Inc. | 07/31/1990SE |
| K901859 | Coat-A-Count Total Ige Irma, Catalog #IKIE1, IKIE2JHR · Traditional | Diagnostic Products Corp. | 05/03/1990SE |
| K882616 | Alternate Procedure, Pharmacia Ige EiaJHR · Traditional | Pharmacia, Inc. | 08/04/1988SE |
| K873077 | Pharmacia Ige EiaJHR · Traditional | Pharmacia, Inc. | 10/20/1987SE |
| K840103 | Radioimmunoassay for Total Ige HumanJHR · Traditional | Techniclone Intl. | 02/10/1984SE |
More from Techniclone Intl.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K982949 | Elecsys Psa, Model 2010LTJ · Traditional | 10/27/1998SE |
Questions and answers
When was Elecys Ige Assay cleared by the FDA?
Elecys Ige Assay (K984326) received a 510(k) decision of Substantially Equivalent on February 8, 1999, 67 days after the submission was received.
What is the product code of K984326?
The FDA product code is JHR – Radioimmunoassay, Immunoglobulins (D, E), a Class II (moderate risk) device regulated under 21 CFR 866.5510.