JIW — Calibrator, Surrogate Class II
FDA Device Classification
Classification Details
- Product Code
- JIW
- Device Class
- Class II
- Regulation Number
- 862.1150
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K973055 | wako chemicals usa | WAKO CH50 LINEARITY SET | September 25, 1997 |
| K970396 | dade chemistry systems | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR | February 20, 1997 |
| K910255 | sigma diagnostics | FLOW CYTOMETRY FITC/PE COMPENSATION KIT | April 3, 1991 |
| K902575 | diagnostic products | SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) | October 4, 1990 |
| K902294 | sigma chemical | ACCUSCAN MICROBEAD STANDARDS | July 3, 1990 |
| K892213 | analytical control systems | ACS COLLOID OSMOTIC PRESSURE CALIBRATOR | June 21, 1989 |
| K883389 | reagents applications | RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD | December 14, 1988 |
| K882220 | king diagnostics | CALIBRATION KIT | August 2, 1988 |
| K880654 | american research products | AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 | June 7, 1988 |
| K880610 | boehringer mannheim | UNIMETER CALIBRATION KIT | March 24, 1988 |
| K854028 | verified medical research | AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER | December 2, 1985 |
| K851450 | flow cytometry standards | FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM | September 16, 1985 |
| K852260 | seragen diagnostics | QUICK-CHEM CALIBRATION SET | July 22, 1985 |
| K812220 | hyland therapeutic div., travenol laboratories | NEPHELOMETRIC SOLID TURBIDITY STANDARD | August 18, 1981 |
| K801300 | e.i. dupont de nemours and co | DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) | July 8, 1980 |
| K800304 | union carbide | CENTRIFICHEM FILTER CALIBRATION SET | March 12, 1980 |
| K790643 | union carbide | CENTRIFICHEM FILTER CALIBRATION SET | May 23, 1979 |