ELECSYS IGE II IMMUNOASSAY
FDA 510(k) clearance K061970 · decided 2006-08-31
Clearance details
- K-number
- K061970
- Device name
- ELECSYS IGE II IMMUNOASSAY
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2006-07-12
- Decision date
- 2006-08-31
- Days to decision
- 50 days
- Clearance type
- Special
- Product code
- JHR
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |