IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
FDA 510(k) clearance K965033 · decided 1997-04-21
Clearance details
- K-number
- K965033
- Device name
- IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-17
- Decision date
- 1997-04-21
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- MGA
- Device class
- 1
- Regulation number
- 866.5400
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Brea, 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 |
|---|---|---|
| BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT (K933078) | Beckman Instruments, Inc. | 1994-01-11 |
Recalls involving this device
No recalls on record reference this clearance.