JIW — Calibrator, Surrogate Class II
FDA product code JIW covers "Calibrator, Surrogate", a Class II medical device regulated under 21 CFR 862.1150. Submissions are reviewed by the Clinical Chemistry panel. At least 17 recent 510(k) clearances have been granted under this product code.
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 |