FDA Product Code
FDA Product Code JHR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K061970 | ELECSYS IGE II IMMUNOASSAY | Roche Diagnostics | 2006-08-31 | Special | PDF ↗ |
| K984326 | ELECYS IGE ASSAY | Boehringer Mannheim Corp. | 1999-02-08 | Traditional | PDF ↗ |
| K960067 | IMMILITE TOTAL IGE | Diagnostic Products Corp. | 1996-02-14 | Traditional | PDF ↗ |
| K931703 | IMMULITE TOTAL IGE | Diagnostic Products Corp. | 1993-08-16 | Traditional | PDF ↗ |
| K903000 | TURBO-RAST SPECIFIC IGE ASSAY | Ventrex Laboratories, Inc. | 1990-07-31 | Traditional | PDF ↗ |
| K901859 | COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 | Diagnostic Products Corp. | 1990-05-03 | Traditional | PDF ↗ |
| K882616 | ALTERNATE PROCEDURE, PHARMACIA IGE EIA | Pharmacia, Inc. | 1988-08-04 | Traditional | PDF ↗ |
| K873077 | PHARMACIA IGE EIA | Pharmacia, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K840103 | RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN | Techniclone Intl. | 1984-02-10 | Traditional | PDF ↗ |
Product code JHR · Class II · Immunology. Data: openFDA.