510(k) K965033
- Device
- IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K965033
- Product code
- MGA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-21
- Date received
- 1996-12-17
- Regulation
- 866.5400
- Classification name
- Alpha-1 Microglobulin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNETTE HELLIE
- Address
- 200 S. Kraemer Blvd., W-337 Box 8000 Brea CA US 92622 92622
FDA Registration Numbers#
- 2084025
- 3017379203
- 3002800697
- 3014325803
- 2050010
- 2245285
- 2050012
- 3003741796
Source Documents#
Other 510(k) Records For Product Code MGA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933078 | BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT | Beckman Instruments, Inc. | 1994-01-11 |
Legacy Summary#
summary
FDA Review#
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