Immilite Total Ige
FDA 510(k) K960067 · Diagnostic Products Corp.
510(k) numberK960067
Submission
- Device name
- Immilite Total Ige
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- January 5, 1996
- Decision date
- February 14, 1996
- 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 |
| K984326 | Elecys Ige AssayJHR · Traditional | Boehringer Mannheim Corp. | 02/08/1999SE |
| 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 |
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Questions and answers
When was Immilite Total Ige cleared by the FDA?
Immilite Total Ige (K960067) received a 510(k) decision of Substantially Equivalent on February 14, 1996, 40 days after the submission was received.
What is the product code of K960067?
The FDA product code is JHR – Radioimmunoassay, Immunoglobulins (D, E), a Class II (moderate risk) device regulated under 21 CFR 866.5510.