BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT
FDA 510(k) clearance K933078 · decided 1994-01-11
Clearance details
- K-number
- K933078
- Device name
- BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-23
- Decision date
- 1994-01-11
- Days to decision
- 202 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 |
|---|---|---|
| IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT (K965033) | Beckman Instruments, Inc. | 1997-04-21 |
Recalls involving this device
No recalls on record reference this clearance.