Product code JQP
- Device name
- Calculator/Data Processing Module, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2100
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K113007 | BIONIME DIABETES MANAGEMENT SYSTEM VI.0 | Bionime Corporation | 2012-02-27 |
| K983468 | FASTTAKE ADAPTER, MODEL # P/N 020-072-01 | Selfcare, Inc. | 1998-12-17 |
| K964460 | THE ROBOLITE | Shai Syg Motion and Innovations, Ltd. | 1997-01-24 |
| K953652 | PRENVAL I | Base Ten Systems, Inc. | 1995-09-15 |
| K934111 | MR7000 WITH TIME MANAGER SOFTWARE (TMS) | Dynatech Laboratories, Inc. | 1994-11-02 |
| K923316 | EXPRESSO CARTRIDGE | Bio-Rad Laboratories, Inc. | 1993-02-23 |
| K893838 | MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER | Ciba Corning Diagnostics Corp. | 1989-08-31 |
| K892060 | CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM | Syva Co. | 1989-08-10 |
| K885292 | COBAS MFC | Roche Diagnostic Systems, Inc. | 1989-03-22 |
| K881194 | RIA-QUICK | Quantitative Technologies, Inc. | 1988-06-01 |
| K871853 | V-MARC 88A COMPUTER | V.Marc, A Div. of Pictorial, Inc. | 1987-07-16 |
| K871339 | KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-05-15 |
| K864557 | 710 PLUS | Ciba Corning Diagnostics Corp. | 1987-02-25 |
| K861844 | GLUCOFACTS DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | 1986-08-12 |
| K861779 | GLUCOFACTS DATA PRINTER | Miles Laboratories, Inc. | 1986-08-08 |
| K861778 | CLINIFACTS 200 DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | 1986-07-02 |
| K861412 | DIRECT READOUT MODULE ACCESSORY | E.I. Dupont DE Nemours & Co., Inc. | 1986-05-23 |
| K854265 | SIMULATOR | Cygnus of South Florida, Inc. | 1986-03-18 |
| K853026 | BIOVATION MAX DATA MANAGEMENT SYSTEM | Biovation, Inc. | 1985-08-02 |
| K851321 | ATAC 2000 CHEMISTRY ANALYZER | Turpen Laboratory Systems, Inc. | 1985-04-25 |
| K850659 | SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER | Syva Co. | 1985-04-01 |
| K844907 | CLINIFACTS 10 DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | 1985-01-18 |
| K843365 | ISO-DATA IMMUNOASSAY NETWORK SYSTEM | Iso-Data, Inc. | 1984-09-27 |
| K842401 | CHEMISTRY CONSOLE | Biovation, Inc. | 1984-09-04 |
| K831830 | LYRIS MODULAR INFO SYSTEM | Biovation, Inc. | 1984-06-25 |
| K834490 | GELSCAN SOFTWARE 2190 | Lkb Instruments, Inc. | 1984-05-01 |
| K840502 | CATS-CLINICAL LAB COMPUTER SOFTWARE- | Precision Technology, Inc. | 1984-04-04 |
| K834300 | HYBRITECH DATA STATION | Hybritech, Inc. | 1984-02-21 |
| K831838 | LABORATORY DATA MGMT SYSTEM SDMS | Vickers America Medical Corp. | 1984-01-24 |
| K833353 | ACLAIM-QAP IBM PERSONAL COMPUTER EDT | American Dade | 1983-12-22 |
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