510(k) K013643
- Device
- AUSAM TOTAL ALBUMIN ASSAY
- Applicant
- Ausam Biotecthnologies, Inc.
- 510(k) number
- K013643
- Product code
- JIQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-08-14
- Date received
- 2001-11-05
- Regulation
- 862.1645
- Classification name
- Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- LYNN ROLAND
- Address
- 50 Rockefeller Plz. New York NY US 10020 10020
FDA Registration Numbers#
- 3005094123
- 1625587
- 1181121
- 2050012
- 1125908
- 3003522182
- 3005333358
- 2013736
- 3003419906
- 3002809144
- 3003593973
- 2050010
- 3024171133
- 3005146144
- 3014255036
- 3004569406
- 9610126
- 1219029
- 3006365273
- 3000148879
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JIQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K141925 | TOTAL PROTEIN URINE/CSF GEN.3 | Roche Diagnostics Operations (Rdo) | 2014-12-09 |
| K991800 | HEMOCHEK URINE COLLECTION KIT | Osborn Group, Inc. | 1999-09-24 |
| K971458 | ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT | Diagnostic Specialties | 1997-09-02 |
| K965035 | IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT | Beckman Instruments, Inc. | 1997-04-17 |
| K944664 | WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR | Wako Chemicals USA, Inc. | 1995-02-07 |
| K936202 | URINARY ALBUMIN TEST PACK | Dupont Medical Products | 1994-05-09 |
| K935662 | SYNERMED IR 500 CHEMISTRY ANALYZER | Synermed, Inc. | 1994-04-26 |
| K903123 | RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT | Reagents Applications, Inc. | 1990-09-14 |
| K902216 | WAKO(TM) MICRO-ALBUMIN | Wako Chemicals USA, Inc. | 1990-06-18 |
| K895883 | BECKMAN MA MICROALBUMIN REAGENT KIT | Beckman Instruments, Inc. | 1989-12-27 |
| K870516 | ALBUMIN SCREEN TEST | Sclavo, Inc. | 1987-10-20 |
| K842915 | SULFOSALICYLIC ACID, 3% W/V | E K Ind., Inc. | 1984-08-10 |