510(k) K984326
- Device
- ELECYS IGE ASSAY
- Applicant
- BOEHRINGER MANNHEIM CORP.
- 510(k) number
- K984326
- Product code
- JHR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-02-08
- Date received
- 1998-12-03
- Regulation
- 866.5510
- Classification name
- Radioimmunoassay, Immunoglobulins (d, E)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PRISCILLA A HAMILL
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 9610126
- 3006198300
- 2517506
- 1036362
- 3002806944
- 2432235
Source Documents#
Other 510(k) Records For Product Code JHR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061970 | ELECSYS IGE II IMMUNOASSAY | Roche Diagnostics | 2006-08-31 |
| K960067 | IMMILITE TOTAL IGE | Diagnostic Products Corp. | 1996-02-14 |
| K931703 | IMMULITE TOTAL IGE | Diagnostic Products Corp. | 1993-08-16 |
| K903000 | TURBO-RAST SPECIFIC IGE ASSAY | Ventrex Laboratories, Inc. | 1990-07-31 |
| K901859 | COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 | Diagnostic Products Corp. | 1990-05-03 |
| K882616 | ALTERNATE PROCEDURE, PHARMACIA IGE EIA | Pharmacia, Inc. | 1988-08-04 |
| K873077 | PHARMACIA IGE EIA | Pharmacia, Inc. | 1987-10-20 |
| K840103 | RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN | Techniclone Intl. | 1984-02-10 |
Legacy Summary#
summary
FDA Review#
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