510(k) K964695
- Device
- IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K964695
- Product code
- DCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-29
- Date received
- 1996-11-22
- Regulation
- 866.5040
- Classification name
- Albumin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRANK MARTE
- Address
- 200 S. Kraemer Blvd. W-337 Brea CA US 92821 92821
FDA Registration Numbers#
- 8040374
- 9614373
- 3005452690
- 8020316
- 2030861
- 3014150341
- 2517506
- 3023197868
- 1000403749
- 3006198300
- 3011989923
- 9680746
- 3000308930
- 1319808
- 2085064
- 1616487
- 3010825766
- 3012471076
- 3002642396
- 1220972
- 3000148879
- 9610126
- 3003795116
- 9610806
- 3019906
- 2084025
- 3005360469
- 3012963943
- 3024463179
- 2250051
- 2050012
- 9610529
- 3031915160
- 2182595
- 2050010
- 1644972
- 3003741796
- 2432235
- 1319681
Source Documents#
Other 510(k) Records For Product Code DCF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153560 | Optilite Low Level Albumin Kit | The Binding Site Group , Ltd. | 2016-08-25 |
| K143118 | Human Microalbumin kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2015-05-26 |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | Beckman Coulter Ireland, Inc. | 2014-10-15 |
| K121045 | HUMAN ALBUMIN CSF KIT | The Binding Site Group , Ltd. | 2013-06-19 |
| K113072 | TINA-QUANT ALBUMIN GEN.2 | Roche Diagnostics Operations | 2012-05-14 |
| K101089 | EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR | Medica Corp. | 2011-07-13 |
| K101203 | TINA-QUANT ALBUMIN GEN 2 | Roche Diagnostics | 2010-09-10 |
| K100853 | COBAS 8000 MODULAR SERIES ANALYZER | Roche Diagnostics Corp. | 2010-09-09 |
| K091486 | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR | Kamiya Biomedical Co. | 2010-04-29 |
| K082251 | SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 | Beckman Coulter, Inc. | 2009-04-08 |
| K061990 | DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL | Dade Behring, Inc. | 2006-09-19 |
| K053553 | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL | Polymedco, Inc. | 2006-03-09 |
| K051191 | DCL MICROALBUMIN ASSAY, MODEL 252-20 | Diagnostic Chemicals , Ltd. | 2005-07-05 |
| K042643 | VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II | Ortho-Clinical Diagnostics, Inc. | 2004-11-18 |
| K033525 | DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 | Dade Behring, Inc. | 2004-01-12 |
Legacy Summary#
summary
FDA Review#
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