Product code CZW— Immunology
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- Classification name
- Complement C3, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5240
- Advisory panel
- Immunology
- Total cleared
- 44
- First cleared
- Most recent
Market context for product code CZW
FDA has cleared devices under product code CZW between 1976 and 2010, filed by 36 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2010
- 2007
- 2006
- 2005
- 2004
- 2003
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1992
- 1991
Top applicants under product code CZW
Recent clearances under product code CZW
- K100179 — SPAPLUS
- K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
- K061852 — DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
- K050665 — N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
- K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
- K032796 — IBL C3D-CIC EIA TEST
- K032035 — SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
- K012361 — TINA-QUANT COMPLEMENT C3C TEST SYSTEM
- K010326 — WAKO AUTOKIT C3
- K000469 — RANDOX COMPLEMENT C3
- K994296 — DIMENSION C3 FLEX REAGENT CARTRIDGE
- K981783 — C3 MININEPH ANTISERUM
- K993437 — K-ASSAY C3
- K991907 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- K983441 — C3
- K964298 — N-ASSAY TIA MULTI V-NL
- K964842 — IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
- K962409 — OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
- K962199 — QUANTEX C3
- K955857 — N PROTEIN STANDARS SY
- K952594 — N PROTEIN STANDARD SY
- K920007 — IL TEST COMPLEMENT 3
- K911900 — RAICHEM SPIA C3 REAGENT
- K902382 — C3C AND C4 RID KITS
- K892125 — EZ COMPLEMENT C2
- K892127 — EZ COMPLEMENT C3
- K890675 — THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4
- K871939 — QM300 C3 ANTIBODY PACK
- K871024 — PRECIMAT(R) C3
- K871346 — DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
- K861362 — IMMUNOMEDICS SERUM ELISA TEST SYSTEM
- K853466 — GILFORD C3 COMPLEMENT REAGENT
- K851286 — RADIAL IMMUNODIFFUSION PLATES C3 & C4
- K850588 — SPQ TEST SYSTEM FOR COMPLEMENT C3
- K834604 — C3 ANTISERUM CONTROL
- K831905 — RABBITT ANTISERUM TO HUMAN C3C
- K830668 — FIAX COMPLEMENT C3 TEST KIT
- K812491 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3
- K810501 — SCRIPPSYSTEM C3 RID KIT
- K801363 — COMPLEMENT C3 NEPHELOMETRIC ASSAY
- K800212 — COMPLEMENT C3 REAGENT SYSTEM
- K791404 — LANCER L-INA ANTI-C3
- K781653 — NEPHELRATE ANTISERUMS C3C
- K760148 — SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN
Data sourced from openFDA. This site is unofficial and independent of the FDA.