JHR
9 FDA 510(k) clearances · Product code
41 daysmedian time to decision
132 days90th percentile
9clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Immunoglobulins (D, E)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ELECSYS IGE II IMMUNOASSAY (K061970) | Roche Diagnostics | 2006-08-31 |
| ELECYS IGE ASSAY (K984326) | Boehringer Mannheim Corp. | 1999-02-08 |
| IMMILITE TOTAL IGE (K960067) | Diagnostic Products Corp. | 1996-02-14 |
| IMMULITE TOTAL IGE (K931703) | Diagnostic Products Corp. | 1993-08-16 |
| TURBO-RAST SPECIFIC IGE ASSAY (K903000) | Ventrex Laboratories, Inc. | 1990-07-31 |
| COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 (K901859) | Diagnostic Products Corp. | 1990-05-03 |
| ALTERNATE PROCEDURE, PHARMACIA IGE EIA (K882616) | Pharmacia, Inc. | 1988-08-04 |
| PHARMACIA IGE EIA (K873077) | Pharmacia, Inc. | 1987-10-20 |
| RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN (K840103) | Techniclone Intl. | 1984-02-10 |
Track JHR automatically
Every clearance here is in the API, with alerts when new ones post.