Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart C — Microbiology Devices](/submissions/MI/subpart-c%E2%80%94microbiology-devices) → [21 CFR 866.2500](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2500) → JTC — Device, Microtiter Diluting/Dispensing # JTC · Device, Microtiter Diluting/Dispensing _Microbiology · 21 CFR 866.2500 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC ## Overview - **Product Code:** JTC - **Device Name:** Device, Microtiter Diluting/Dispensing - **Regulation:** [21 CFR 866.2500](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2500) - **Device Class:** 1 - **Review Panel:** [Microbiology](/submissions/MI) ## Identification A microtiter diluting and dispensing device is a mechanical device intended for medical purposes to dispense or serially dilute very small quantities of biological or chemical reagents for use in various diagnostic procedures. ## 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 § 866.9. ## Recent Cleared Devices (20 of 66) Showing 20 most recent of 66 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K924907](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K924907.md) | FILTERMATE UNIVERSAL HARVESTER | Packard Instrument Co., Inc. | Dec 1, 1992 | SESE | | [K901808](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K901808.md) | MICROMATE 196 MODEL A961960 | Packard Instrument Co., Inc. | Jun 20, 1990 | SESE | | [K894645](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K894645.md) | IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM | Dynatech Laboratories, Inc. | Oct 17, 1989 | SESE | | [K892369](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K892369.md) | MULTI-PROBE HEAD PLUS | Hamilton Co. | Jun 2, 1989 | SESE | | [K891768](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K891768.md) | GENETIC SYSTEMS MICROPLATE WASHER | Genetic Systems Corp. | May 1, 1989 | SESE | | [K891766](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K891766.md) | GENETIC SYSTEMS MICROPLATE STRIP WASHER | Genetic Systems Corp. | May 1, 1989 | SESE | | [K891765](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K891765.md) | GENETIC SYSTEMS PIPETTOR/DILUTOR | Genetic Systems Corp. | May 1, 1989 | SESE | | [K884695](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K884695.md) | WASHER 500 MICROELISA SYSTEM | Organon Teknika Corp. | Dec 13, 1988 | SESE | | [K884125](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K884125.md) | BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 | Bio-Tek Instruments, Inc. | Dec 2, 1988 | SESE | | [K874598](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K874598.md) | DYNATECH MR 250 MANUAL MICROELISA READER | Dynatech Laboratories, Inc. | Nov 20, 1987 | SESE | | [K873542](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K873542.md) | MICROPLATE AUTO-WASHER (MOTORIZED STAGE) | Genetic Systems Corp. | Sep 23, 1987 | SESE | | [K871945](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K871945.md) | MICROLAB AT | Hamilton Co. | May 29, 1987 | SESE | | [K863423](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K863423.md) | CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 | Plastic Injectors, Inc. | Sep 16, 1986 | SESE | | [K863374](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K863374.md) | CODE-A-WELL SERIES 1-600, 1-625 | Plastic Injectors, Inc. | Sep 11, 1986 | SESE | | [K862802](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K862802.md) | MULTI-CHANNEL MICROPIPETTES | Dynatech Laboratories, Inc. | Aug 1, 1986 | SESE | | [K862066](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K862066.md) | TITERTEK MICROPLATE WASHER S-12 | Flow Laboratories, Inc. | Jun 5, 1986 | SESE | | [K860617](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K860617.md) | POLYPET | Instrumed, Inc. | Mar 3, 1986 | SESE | | [K853920](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K853920.md) | BIO-TEK EL 401 HANDHELD MICROPLATE WASHER | Bio-Tek Instruments, Inc. | Oct 22, 1985 | SESE | | [K853380](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K853380.md) | SPR 2 AUTODILUTER | Scientific Sales Intl., Inc. | Sep 12, 1985 | SESE | | [K851020](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC/K851020.md) | MIC-CONCEPT INOCULATOR | Microtech Medical Systems, Inc. | Mar 29, 1985 | SESE | ## Top Applicants - Dynatech Laboratories, Inc. — 12 clearances - Dynatech Corp. — 6 clearances - Corning Costar Corp. — 5 clearances - Flow Laboratories, Inc. — 5 clearances - Genetic Systems Corp. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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