Product code JIW— Clinical Chemistry
CENTRIFICHEM FILTER CALIBRATION SET
- Classification name
- Calibrator, Surrogate
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code JIW
FDA has cleared devices under product code JIW between 1979 and 1997, filed by 16 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
- 1997
- 1991
- 1990
- 1989
- 1988
- 1985
- 1981
- 1980
- 1979
Top applicants under product code JIW
Recent clearances under product code JIW
- K973055 — WAKO CH50 LINEARITY SET
- K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
- K910255 — FLOW CYTOMETRY FITC/PE COMPENSATION KIT
- K902575 — SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)
- K902294 — ACCUSCAN MICROBEAD STANDARDS
- K892213 — ACS COLLOID OSMOTIC PRESSURE CALIBRATOR
- K883389 — RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD
- K882220 — CALIBRATION KIT
- K880654 — AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200
- K880610 — UNIMETER CALIBRATION KIT
- K854028 — AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER
- K851450 — FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM
- K852260 — QUICK-CHEM CALIBRATION SET
- K812220 — NEPHELOMETRIC SOLID TURBIDITY STANDARD
- K801300 — DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
- K800304 — CENTRIFICHEM FILTER CALIBRATION SET
- K790643 — CENTRIFICHEM FILTER CALIBRATION SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.