510(k) K123322
- Device
- ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
- Applicant
- ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
- 510(k) number
- K123322
- Product code
- CDN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-05-21
- Date received
- 2012-10-26
- Regulation
- 862.1770
- Classification name
- Urease, Photometric, Urea Nitrogen
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HYMAN KATZ PH.D.
- Address
- 4 Henderson Dr. West Caldwell NJ US 07006 07006
FDA Registration Numbers#
- 2939693
- 2085064
- 3012963943
- 3002642396
- 2250051
- 2247288
- 1319809
- 3000308930
- 1319681
Source Documents#
Other 510(k) Records For Product Code CDN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019-03-14 |
| K132462 | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | Hitachi Chemical Diagnostics, Inc. | 2013-10-28 |
| K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-10 |
| K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD | Alfa Wassermann Diagnostic Technologies, Inc. | 2011-09-08 |
| K001885 | VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | Ortho-Clinical Diagnostics, Inc. | 2000-07-20 |
| K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM | Cholestech Corp. | 1997-07-24 |
| K961196 | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-15 |
| K943042 | BUN QVET | Prisma Systems | 1994-12-29 |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | King Diagnostics, Inc. | 1992-10-13 |
| K914903 | QUICKSTART UREA NITROGEN | Em Diagnostic Systems, Inc. | 1991-12-31 |
| K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION | The Dow Chemical Co. | 1982-08-05 |
| K802518 | BUN REAGENT ASTRA 4 & 8 ANALYZERS | Nobel Scientific Industries, Inc. | 1980-11-12 |
| K792328 | STATTEK BUN | Boehringer Mannheim Corp. | 1979-12-18 |
| K781253 | BUN (UREASE) REAGENT | Coulter Electronics, Inc. | 1978-08-21 |
| K771442 | MULTISTAT III UREA NITROGEN TEST | Instrumentation Laboratory CO | 1977-08-22 |
Legacy Summary#
summary
FDA Review#
Decision Summary