IMMULITE TOTAL IGE
FDA 510(k) clearance K931703 · decided 1993-08-16
Clearance details
- K-number
- K931703
- Device name
- IMMULITE TOTAL IGE
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-06
- Decision date
- 1993-08-16
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- JHR
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens He recall (Z-1517-2014) | Siemens Healthcare Diagnostics | 2014-04-25 |
| IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KI recall (Z-1518-2014) | Siemens Healthcare Diagnostics | 2014-04-25 |