Panels › Immunology › Product code JHR · Class 2
Radioimmunoassay, Immunoglobulins (D, E)
Regulation 866.5510
0510(k)s in 12 months (9 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JHR
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Products Corp. | 3 | 0 |
| Pharmacia, Inc. | 2 | 0 |
| Siemens Healthcare Diagnostics | 0 | 2 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Roche Diagnostics | 1 | 0 |
| Techniclone Intl. | 1 | 0 |
| Ventrex Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 31, 2006 | K061970 | ELECSYS IGE II IMMUNOASSAY Roche Diagnostics | JHR |
| Feb 8, 1999 | K984326 | ELECYS IGE ASSAY Boehringer Mannheim Corp. | JHR |
| Feb 14, 1996 | K960067 | IMMILITE TOTAL IGE Diagnostic Products Corp. | JHR |
| Aug 16, 1993 | K931703 | IMMULITE TOTAL IGE Diagnostic Products Corp. | JHR |
| Jul 31, 1990 | K903000 | TURBO-RAST SPECIFIC IGE ASSAY Ventrex Laboratories, Inc. | JHR |
| May 3, 1990 | K901859 | COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 Diagnostic Products Corp. | JHR |
| Aug 4, 1988 | K882616 | ALTERNATE PROCEDURE, PHARMACIA IGE EIA Pharmacia, Inc. | JHR |
| Oct 20, 1987 | K873077 | PHARMACIA IGE EIA Pharmacia, Inc. | JHR |
| Feb 10, 1984 | K840103 | RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN Techniclone Intl. | JHR |
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