JQP · Calculator/Data Processing Module, For Clinical Use
Clinical Chemistry · 21 CFR 862.2100 · Class 1
Overview
| Product Code | JQP |
|---|---|
| Device Name | Calculator/Data Processing Module, For Clinical Use |
| Regulation | 21 CFR 862.2100 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.
Classification Rationale
Class I (general 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 (20 of 78)
Showing 20 most recent of 78 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K113007 | BIONIME DIABETES MANAGEMENT SYSTEM VI.0 | Bionime Corporation | Feb 27, 2012 | SESE |
| K983468 | FASTTAKE ADAPTER, MODEL # P/N 020-072-01 | Selfcare, Inc. | Dec 17, 1998 | SESE |
| K964460 | THE ROBOLITE | Shai Syg Motion and Innovations, Ltd. | Jan 24, 1997 | SESE |
| K953652 | PRENVAL I | Base Ten Systems, Inc. | Sep 15, 1995 | SESE |
| K934111 | MR7000 WITH TIME MANAGER SOFTWARE (TMS) | Dynatech Laboratories, Inc. | Nov 2, 1994 | SESE |
| K923316 | EXPRESSO CARTRIDGE | Bio-Rad Laboratories, Inc. | Feb 23, 1993 | SESE |
| K893838 | MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER | Ciba Corning Diagnostics Corp. | Aug 31, 1989 | SESE |
| K892060 | CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM | Syva Co. | Aug 10, 1989 | SESE |
| K885292 | COBAS MFC | Roche Diagnostic Systems, Inc. | Mar 22, 1989 | SESE |
| K881194 | RIA-QUICK | Quantitative Technologies, Inc. | Jun 1, 1988 | SESE |
| K871853 | V-MARC 88A COMPUTER | V.Marc, A Div. of Pictorial, Inc. | Jul 16, 1987 | SESE |
| K871339 | KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM | Kallestad Diag, A Div. of Erbamont, Inc. | May 15, 1987 | SESE |
| K864557 | 710 PLUS | Ciba Corning Diagnostics Corp. | Feb 25, 1987 | SESE |
| K861844 | GLUCOFACTS DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | Aug 12, 1986 | SESE |
| K861779 | GLUCOFACTS DATA PRINTER | Miles Laboratories, Inc. | Aug 8, 1986 | SESE |
| K861778 | CLINIFACTS 200 DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | Jul 2, 1986 | SESE |
| K861412 | DIRECT READOUT MODULE ACCESSORY | E.I. Dupont DE Nemours & Co., Inc. | May 23, 1986 | SESE |
| K854265 | SIMULATOR | Cygnus of South Florida, Inc. | Mar 18, 1986 | SESE |
| K853026 | BIOVATION MAX DATA MANAGEMENT SYSTEM | Biovation, Inc. | Aug 2, 1985 | SESE |
| K851321 | ATAC 2000 CHEMISTRY ANALYZER | Turpen Laboratory Systems, Inc. | Apr 25, 1985 | SESE |
Top Applicants
- Miles Laboratories, Inc. — 8 clearances
- Syva Co. — 7 clearances
- Instrumentation Laboratory CO — 5 clearances
- Biovation, Inc. — 4 clearances
- Corning Medical & Scientific — 4 clearances
