JTC · Device, Microtiter Diluting/Dispensing
Microbiology · 21 CFR 866.2500 · Class 1
Overview
| Product Code | JTC |
|---|---|
| Device Name | Device, Microtiter Diluting/Dispensing |
| Regulation | 21 CFR 866.2500 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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 | FILTERMATE UNIVERSAL HARVESTER | Packard Instrument Co., Inc. | Dec 1, 1992 | SESE |
| K901808 | MICROMATE 196 MODEL A961960 | Packard Instrument Co., Inc. | Jun 20, 1990 | SESE |
| K894645 | IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM | Dynatech Laboratories, Inc. | Oct 17, 1989 | SESE |
| K892369 | MULTI-PROBE HEAD PLUS | Hamilton Co. | Jun 2, 1989 | SESE |
| K891768 | GENETIC SYSTEMS MICROPLATE WASHER | Genetic Systems Corp. | May 1, 1989 | SESE |
| K891766 | GENETIC SYSTEMS MICROPLATE STRIP WASHER | Genetic Systems Corp. | May 1, 1989 | SESE |
| K891765 | GENETIC SYSTEMS PIPETTOR/DILUTOR | Genetic Systems Corp. | May 1, 1989 | SESE |
| K884695 | WASHER 500 MICROELISA SYSTEM | Organon Teknika Corp. | Dec 13, 1988 | SESE |
| K884125 | BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 | Bio-Tek Instruments, Inc. | Dec 2, 1988 | SESE |
| K874598 | DYNATECH MR 250 MANUAL MICROELISA READER | Dynatech Laboratories, Inc. | Nov 20, 1987 | SESE |
| K873542 | MICROPLATE AUTO-WASHER (MOTORIZED STAGE) | Genetic Systems Corp. | Sep 23, 1987 | SESE |
| K871945 | MICROLAB AT | Hamilton Co. | May 29, 1987 | SESE |
| K863423 | CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 | Plastic Injectors, Inc. | Sep 16, 1986 | SESE |
| K863374 | CODE-A-WELL SERIES 1-600, 1-625 | Plastic Injectors, Inc. | Sep 11, 1986 | SESE |
| K862802 | MULTI-CHANNEL MICROPIPETTES | Dynatech Laboratories, Inc. | Aug 1, 1986 | SESE |
| K862066 | TITERTEK MICROPLATE WASHER S-12 | Flow Laboratories, Inc. | Jun 5, 1986 | SESE |
| K860617 | POLYPET | Instrumed, Inc. | Mar 3, 1986 | SESE |
| K853920 | BIO-TEK EL 401 HANDHELD MICROPLATE WASHER | Bio-Tek Instruments, Inc. | Oct 22, 1985 | SESE |
| K853380 | SPR 2 AUTODILUTER | Scientific Sales Intl., Inc. | Sep 12, 1985 | SESE |
| K851020 | MIC-CONCEPT INOCULATOR | Microtech Medical Systems, Inc. | Mar 29, 1985 | SESE |
Top Applicants
- Dynatech Laboratories, Inc. — 12 clearances
- Dynatech Corp. — 6 clearances
- Flow Laboratories, Inc. — 5 clearances
- Corning Costar Corp. — 5 clearances
- Genetic Systems Corp. — 4 clearances
