N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)
FDA 510(k) clearance K890530 · decided 1989-03-27
Clearance details
- K-number
- K890530
- Device name
- N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-02
- Decision date
- 1989-03-27
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- DGC
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |