FDA Product Code
FDA Product Code JQP — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2100
510(k) Clearances — 78 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K113007 | BIONIME DIABETES MANAGEMENT SYSTEM VI.0 | Bionime Corporation | 2012-02-27 | Traditional | PDF ↗ |
| K983468 | FASTTAKE ADAPTER, MODEL # P/N 020-072-01 | Selfcare, Inc. | 1998-12-17 | Traditional | PDF ↗ |
| K964460 | THE ROBOLITE | Shai Syg Motion and Innovations, Ltd. | 1997-01-24 | Traditional | PDF ↗ |
| K953652 | PRENVAL I | Base Ten Systems, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K934111 | MR7000 WITH TIME MANAGER SOFTWARE (TMS) | Dynatech Laboratories, Inc. | 1994-11-02 | Traditional | PDF ↗ |
| K923316 | EXPRESSO CARTRIDGE | Bio-Rad Laboratories, Inc. | 1993-02-23 | Traditional | PDF ↗ |
| K893838 | MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER | Ciba Corning Diagnostics Corp. | 1989-08-31 | Traditional | PDF ↗ |
| K892060 | CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM | Syva Co. | 1989-08-10 | Traditional | PDF ↗ |
| K885292 | COBAS MFC | Roche Diagnostic Systems, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K881194 | RIA-QUICK | Quantitative Technologies, Inc. | 1988-06-01 | Traditional | PDF ↗ |
| K871853 | V-MARC 88A COMPUTER | V.Marc, A Div. of Pictorial, Inc. | 1987-07-16 | Traditional | PDF ↗ |
| K871339 | KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-05-15 | Traditional | PDF ↗ |
| K864557 | 710 PLUS | Ciba Corning Diagnostics Corp. | 1987-02-25 | Traditional | PDF ↗ |
| K861844 | GLUCOFACTS DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | 1986-08-12 | Traditional | PDF ↗ |
| K861779 | GLUCOFACTS DATA PRINTER | Miles Laboratories, Inc. | 1986-08-08 | Traditional | PDF ↗ |
| K861778 | CLINIFACTS 200 DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | 1986-07-02 | Traditional | PDF ↗ |
| K861412 | DIRECT READOUT MODULE ACCESSORY | E.I. Dupont DE Nemours & Co., Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K854265 | SIMULATOR | Cygnus of South Florida, Inc. | 1986-03-18 | Traditional | PDF ↗ |
| K853026 | BIOVATION MAX DATA MANAGEMENT SYSTEM | Biovation, Inc. | 1985-08-02 | Traditional | PDF ↗ |
| K851321 | ATAC 2000 CHEMISTRY ANALYZER | Turpen Laboratory Systems, Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K850659 | SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER | Syva Co. | 1985-04-01 | Traditional | PDF ↗ |
| K844907 | CLINIFACTS 10 DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | 1985-01-18 | Traditional | PDF ↗ |
| K843365 | ISO-DATA IMMUNOASSAY NETWORK SYSTEM | Iso-Data, Inc. | 1984-09-27 | Traditional | PDF ↗ |
| K842401 | CHEMISTRY CONSOLE | Biovation, Inc. | 1984-09-04 | Traditional | PDF ↗ |
| K831830 | LYRIS MODULAR INFO SYSTEM | Biovation, Inc. | 1984-06-25 | Traditional | PDF ↗ |
| K834490 | GELSCAN SOFTWARE 2190 | Lkb Instruments, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K840502 | CATS-CLINICAL LAB COMPUTER SOFTWARE- | Precision Technology, Inc. | 1984-04-04 | Traditional | PDF ↗ |
| K834300 | HYBRITECH DATA STATION | Hybritech, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K831838 | LABORATORY DATA MGMT SYSTEM SDMS | Vickers America Medical Corp. | 1984-01-24 | Traditional | PDF ↗ |
| K833353 | ACLAIM-QAP IBM PERSONAL COMPUTER EDT | American Dade | 1983-12-22 | Traditional | PDF ↗ |
| K832746 | DUPONT LINEARIZATION MODULE | E.I. Dupont DE Nemours & Co., Inc. | 1983-11-25 | Traditional | PDF ↗ |
| K832760 | RIA SOFTWARE | Kemble Instruments, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K831574 | BLOOD GAS QUALITY CONTROL SOFT-86000F | Computermate, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K830296 | CORNING 102 PRINTER | Corning Medical & Scientific | 1983-03-25 | Traditional | PDF ↗ |
| K823785 | API MDS* | Analytical Products, Inc. | 1983-01-09 | Traditional | PDF ↗ |
| K823679 | NML 6000 CT | Nuclear Medical Laboratories, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K822778 | BLOOD GAS EXPER. SYSTEM 8700 | Exper Corp., Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K823110 | QAP MICROCOMPUTER SYSTEM | American Dade | 1982-11-16 | Traditional | PDF ↗ |
| K822932 | EMIT CLINICAL PROCESSOR #CP-5000 | Syva Co. | 1982-11-05 | Traditional | PDF ↗ |
| K822860 | RIA SSIST TI-59 MAGNETIC CARD PROGRAMS | Ventrex Laboratories, Inc. | 1982-10-27 | Traditional | PDF ↗ |
| K822381 | SYVA LAB PROCESSOR 6000 | Syva Co. | 1982-08-27 | Traditional | PDF ↗ |
| K822146 | CORNING 101 PRINTER | Corning Medical & Scientific | 1982-08-05 | Traditional | PDF ↗ |
| K821807 | AMERIFLOUR FLUOROMETER | American Diagnostic Corp. | 1982-07-02 | Traditional | PDF ↗ |
| K821531 | EMIT TIMER UNIT #100 | Syva Co. | 1982-06-11 | Traditional | PDF ↗ |
| K821058 | 715 DELTA TERMINAL | Corning Medical & Scientific | 1982-05-03 | Traditional | PDF ↗ |
| K820721 | COMPUTERIZED INTERPRETATION OF ARTERIAL | Philip R. Corsello, M.D. | 1982-04-01 | Traditional | PDF ↗ |
| K820427 | IL 8060 DATA MANAGEMENT SYSTEM | Instrumentation Laboratory CO | 1982-03-11 | Traditional | PDF ↗ |
| K812604 | BIOVATION URINALYSIS REPORTER | Biovation, Inc. | 1981-10-02 | Traditional | PDF ↗ |
| K810968 | BCD-HPP41C INTERFACE | Dynatech Corp. | 1981-04-23 | Traditional | PDF ↗ |
| K810631 | DPM CALCULATOR | Iso-Data, Inc. | 1981-03-27 | Traditional | PDF ↗ |
| K803312 | MICROMEDIC AUTOMATIC COMPUTING CENTER | Micomedic Systems | 1981-02-04 | Traditional | PDF ↗ |
| K810063 | AUTOMATIC BIOCHEMICAL ANALYZER | Acculab | 1981-01-26 | Traditional | PDF ↗ |
| K802594 | BECKMAN DP-5500 DATA REDUCTION SYSTEM | Beckman Instruments, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802471 | CHEMTROLER | Fletcher Flora Computer Products, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802251 | SP 120 SOPHISTICATE | Vickers America Medical Corp. | 1980-10-23 | Traditional | PDF ↗ |
| K801664 | SERALYZER GLUCOSE TEST MODULE | Miles Laboratories, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K801438 | CENTRIFICHEM SYSTEM MANAGER | Union Carbide Corp. | 1980-07-28 | Traditional | PDF ↗ |
| K801210 | BIOSTATOR PRINTER/PLOTTER | Miles Laboratories, Inc. | 1980-06-17 | Traditional | PDF ↗ |
| K801167 | CENTRIFICHEM SYSTEM 400 | Union Carbide Corp. | 1980-06-09 | Traditional | PDF ↗ |
| K801091 | K 750 COMPUTER/DATA PROCESSOR | J.T. Baker Chemical Co. | 1980-06-09 | Traditional | PDF ↗ |
| K801131 | IL88640 & 88641 CASSETTE-TAPE PROGRAM | Instrumentation Laboratory CO | 1980-05-23 | Traditional | PDF ↗ |
| K800724 | AMES LAB MANAGEMENT SYSTEM | Miles Laboratories, Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K800282 | DATA MANAGEMENT SYSTEM IL MODEL 775 | Instrumentation Laboratory CO | 1980-03-05 | Traditional | PDF ↗ |
| K800242 | MICRO MEDICAL DATA SYSTEM II | Micro/Tel., Inc. | 1980-03-03 | Traditional | PDF ↗ |
| K800241 | MICRO MEDICAL DATA SYSTEM | Micro/Tel., Inc. | 1980-02-26 | Traditional | PDF ↗ |
| K792158 | 3388 REPORTING INTEGRATOR | Hewlett-Packard Co. | 1979-11-16 | Traditional | PDF ↗ |
| K792129 | EMIT CLINICAL PROCESSOR-CP 5000 | Syva Co. | 1979-11-13 | Traditional | PDF ↗ |
| K790543 | THE ABBOTT EXECUTIVE | Abbott Laboratories | 1979-05-03 | Traditional | PDF ↗ |
| K790336 | UNION CARBIDE CORP. COMPUTER INTERFACE | Union Carbide Corp. | 1979-04-04 | Traditional | PDF ↗ |
| K782052 | PROCESSOR, K750 COMPUTER/DATA | Kallestad Laboratories, Inc. | 1979-01-17 | Traditional | PDF ↗ |
| K781081 | EMIT MCA PROGRAM TAPE | Instrumentation Laboratory CO | 1978-09-27 | Traditional | PDF ↗ |
| K781173 | COMPUTER INTERFACE IL 814 | Instrumentation Laboratory CO | 1978-09-14 | Traditional | PDF ↗ |
| K781217 | DATA TERMINAL MODEL 722 | Corning Medical & Scientific | 1978-08-21 | Traditional | PDF ↗ |
| K780881 | EMIT CLINICAL PROCESSOR - CP 5000 | Syva Co. | 1978-06-22 | Traditional | PDF ↗ |
| K770877 | DATA REDUCTION SYSTEM, DP-3000 | Beckman Instruments, Inc. | 1977-07-21 | Traditional | PDF ↗ |
| K770671 | CALCULATOR, ENZYME, TURNER | Turner Assoc. | 1977-06-27 | Traditional | PDF ↗ |
| K761063 | GAMMACORD II CALCULATOR INTERFACE | Miles Laboratories, Inc. | 1976-12-02 | Traditional | PDF ↗ |
| K760739 | ACA DATA MATE ACCESSORY | E.I. Dupont DE Nemours & Co., Inc. | 1976-11-16 | Traditional | PDF ↗ |
Product code JQP · Class I · Clinical Chemistry. Data: openFDA.