Elecsys Ige II Immunoassay
FDA 510(k) K061970 · Roche Diagnostics
510(k) numberK061970
Submission
- Device name
- Elecsys Ige II Immunoassay
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- July 12, 2006
- Decision date
- August 31, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | Boehringer Mannheim Corp. | 02/08/1999SE |
| 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 |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Elecsys Ige II Immunoassay cleared by the FDA?
Elecsys Ige II Immunoassay (K061970) received a 510(k) decision of Substantially Equivalent on August 31, 2006, 50 days after the submission was received.
What is the product code of K061970?
The FDA product code is JHR – Radioimmunoassay, Immunoglobulins (D, E), a Class II (moderate risk) device regulated under 21 CFR 866.5510.