JIW · Calibrator, Surrogate
Clinical Chemistry · 21 CFR 862.1150 · Class 2
Overview
| Product Code | JIW |
|---|---|
| Device Name | Calibrator, Surrogate |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973055 | WAKO CH50 LINEARITY SET | Wako Chemicals USA, Inc. | Sep 25, 1997 | SESE |
| K970396 | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR | Dade Chemistry Systems, Inc. | Feb 20, 1997 | SESE |
| K910255 | FLOW CYTOMETRY FITC/PE COMPENSATION KIT | Sigma Diagnostics, Inc. | Apr 3, 1991 | SESE |
| K902575 | SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) | Diagnostic Products Corp. | Oct 4, 1990 | SESE |
| K902294 | ACCUSCAN MICROBEAD STANDARDS | Sigma Chemical Co. | Jul 3, 1990 | SESE |
| K892213 | ACS COLLOID OSMOTIC PRESSURE CALIBRATOR | Analytical Control Systems, Inc. | Jun 21, 1989 | SESE |
| K883389 | RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD | Reagents Applications, Inc. | Dec 14, 1988 | SESE |
| K882220 | CALIBRATION KIT | King Diagnostics, Inc. | Aug 2, 1988 | SESE |
| K880654 | AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 | American Research Products Co. | Jun 7, 1988 | SESE |
| K880610 | UNIMETER CALIBRATION KIT | Boehringer Mannheim Corp. | Mar 24, 1988 | SESE |
| K854028 | AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER | Verified Medical Research, Inc. | Dec 2, 1985 | SESE |
| K851450 | FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM | Flow Cytometry Standards Corp. | Sep 16, 1985 | SESE |
| K852260 | QUICK-CHEM CALIBRATION SET | Seragen Diagnostics, Inc. | Jul 22, 1985 | SESE |
| K812220 | NEPHELOMETRIC SOLID TURBIDITY STANDARD | Hyland Therapeutic Div., Travenol Laboratories | Aug 18, 1981 | SESE |
| K801300 | DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) | E.I. Dupont DE Nemours & Co., Inc. | Jul 8, 1980 | SESE |
| K800304 | CENTRIFICHEM FILTER CALIBRATION SET | Union Carbide Corp. | Mar 12, 1980 | SESE |
| K790643 | CENTRIFICHEM FILTER CALIBRATION SET | Union Carbide Corp. | May 23, 1979 | SESE |
Top Applicants
- Union Carbide Corp. — 2 clearances
- American Research Products Co. — 1 clearance
- Analytical Control Systems, Inc. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Dade Chemistry Systems, Inc. — 1 clearance
