BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL
FDA 510(k) clearance K951635 · decided 1995-05-15
Clearance details
- K-number
- K951635
- Device name
- BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-07
- Decision date
- 1995-05-15
- Days to decision
- 38 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TINA-QUANT IGG GEN.2 (K050113) | Roche Diagnostics Corp. | 2005-02-08 |
| ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (K040434) | Roche Diagnostics Corp. | 2004-03-10 |
| SPIFE IFE CALIBRATOR AND CONTROL KIT (K010617) | Helena Laboratories | 2001-03-15 |
| WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (K993928) | Wako Chemicals USA, Inc. | 2000-01-18 |
| K-ASSAY IGG (K993281) | Kamiya Biomedical Co. | 1999-11-09 |
| 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 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (K963868) | Beckman Instruments, Inc. | 1997-02-10 |
| QUANTEX IGG (K962202) | Instrumentation Laboratory CO | 1996-09-26 |
| IGG IMMUNOTURBIDIMETRIC & CALIBRATOR (K955798) | Randox Laboratories, Ltd. | 1996-04-05 |
| BEHRING NEPHELOMETER II (K943997) | Behring Diagnostics, Inc. | 1994-10-03 |
Recalls involving this device
No recalls on record reference this clearance.