510(k) K914391
- Device
- ALBUMIN TEST RID KIT
- Applicant
- THE BINDING SITE, LTD.
- 510(k) number
- K914391
- Product code
- DCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-12-10
- Date received
- 1991-10-01
- Regulation
- 866.5040
- Classification name
- Albumin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- JAY H GELLER
- Address
- Westside Towers, Suite 1000 11845 W. Olympic Blvd. Los Angeles CA US 90064 90064
FDA Registration Numbers
- 2084025
- 8020316
- 3006198300
- 3005360469
- 3003795116
- 2030861
- 9610806
- 9680746
- 2050012
- 3003741796
- 9610529
- 3031915160
- 2432235
- 3012963943
- 2250051
- 3014150341
- 1319808
- 8040374
- 2182595
- 1000403749
- 3024463179
- 2517506
- 1644972
- 3011989923
- 3019906
- 3002642396
- 2050010
- 3010825766
- 3005452690
- 3012471076
- 3023197868
- 2085064
- 1616487
- 9610126
- 1220972
- 1319681
- 3000308930
- 3000148879
- 9614373
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051700010689 | Human Albumin NL BINDARID™ Radial Immunodiffusion | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
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
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FDA Review
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