Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2100](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2100) → JQP — Calculator/Data Processing Module, For Clinical Use # JQP · Calculator/Data Processing Module, For Clinical Use _Clinical Chemistry · 21 CFR 862.2100 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP ## Overview - **Product Code:** JQP - **Device Name:** Calculator/Data Processing Module, For Clinical Use - **Regulation:** [21 CFR 862.2100](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2100) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## 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](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K113007.md) | BIONIME DIABETES MANAGEMENT SYSTEM VI.0 | Bionime Corporation | Feb 27, 2012 | SESE | | [K983468](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K983468.md) | FASTTAKE ADAPTER, MODEL # P/N 020-072-01 | Selfcare, Inc. | Dec 17, 1998 | SESE | | [K964460](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K964460.md) | THE ROBOLITE | Shai Syg Motion and Innovations, Ltd. | Jan 24, 1997 | SESE | | [K953652](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K953652.md) | PRENVAL I | Base Ten Systems, Inc. | Sep 15, 1995 | SESE | | [K934111](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K934111.md) | MR7000 WITH TIME MANAGER SOFTWARE (TMS) | Dynatech Laboratories, Inc. | Nov 2, 1994 | SESE | | [K923316](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K923316.md) | EXPRESSO CARTRIDGE | Bio-Rad Laboratories, Inc. | Feb 23, 1993 | SESE | | [K893838](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K893838.md) | MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER | Ciba Corning Diagnostics Corp. | Aug 31, 1989 | SESE | | [K892060](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K892060.md) | CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM | Syva Co. | Aug 10, 1989 | SESE | | [K885292](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K885292.md) | COBAS MFC | Roche Diagnostic Systems, Inc. | Mar 22, 1989 | SESE | | [K881194](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K881194.md) | RIA-QUICK | Quantitative Technologies, Inc. | Jun 1, 1988 | SESE | | [K871853](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K871853.md) | V-MARC 88A COMPUTER | V.Marc, A Div. of Pictorial, Inc. | Jul 16, 1987 | SESE | | [K871339](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K871339.md) | KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM | Kallestad Diag, A Div. of Erbamont, Inc. | May 15, 1987 | SESE | | [K864557](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K864557.md) | 710 PLUS | Ciba Corning Diagnostics Corp. | Feb 25, 1987 | SESE | | [K861844](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K861844.md) | GLUCOFACTS DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | Aug 12, 1986 | SESE | | [K861779](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K861779.md) | GLUCOFACTS DATA PRINTER | Miles Laboratories, Inc. | Aug 8, 1986 | SESE | | [K861778](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K861778.md) | CLINIFACTS 200 DATA MANAGEMENT SYSTEM | Miles Laboratories, Inc. | Jul 2, 1986 | SESE | | [K861412](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K861412.md) | DIRECT READOUT MODULE ACCESSORY | E.I. Dupont DE Nemours & Co., Inc. | May 23, 1986 | SESE | | [K854265](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K854265.md) | SIMULATOR | Cygnus of South Florida, Inc. | Mar 18, 1986 | SESE | | [K853026](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K853026.md) | BIOVATION MAX DATA MANAGEMENT SYSTEM | Biovation, Inc. | Aug 2, 1985 | SESE | | [K851321](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K851321.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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