IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
FDA 510(k) clearance K963868 · decided 1997-02-10
Clearance details
- K-number
- K963868
- Device name
- IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-26
- Decision date
- 1997-02-10
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- DEW
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| IGG (K983221) | Abbott Laboratories | 1998-11-04 |
| SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (K965108) | Beckman Instruments, Inc. | 1997-03-06 |
| IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (K963974) | Beckman Instruments, Inc. | 1997-03-06 |
| QUANTEX IGG (K962202) | Instrumentation Laboratory CO | 1996-09-26 |
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| BEHRING NEPHELOMETER II (K943997) | Behring Diagnostics, Inc. | 1994-10-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when u recall (Z-0118-2025) | Beckman Coulter Inc. | 2024-10-17 |
| IMMAGE IgM Reagent Part No.: 447610 recall (Z-1150-04) | Beckman Coulter Inc | 2004-07-23 |