JHR — Radioimmunoassay, Immunoglobulins (D, E) Class II
FDA Device Classification
Classification Details
- Product Code
- JHR
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K061970 | roche diagnostics | ELECSYS IGE II IMMUNOASSAY | August 31, 2006 |
| K984326 | boehringer mannheim | ELECYS IGE ASSAY | February 8, 1999 |
| K960067 | diagnostic products | IMMILITE TOTAL IGE | February 14, 1996 |
| K931703 | diagnostic products | IMMULITE TOTAL IGE | August 16, 1993 |
| K903000 | ventrex laboratories | TURBO-RAST SPECIFIC IGE ASSAY | July 31, 1990 |
| K901859 | diagnostic products | COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 | May 3, 1990 |
| K882616 | pharmacia | ALTERNATE PROCEDURE, PHARMACIA IGE EIA | August 4, 1988 |
| K873077 | pharmacia | PHARMACIA IGE EIA | October 20, 1987 |
| K840103 | techniclone intl | RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN | February 10, 1984 |