FDA product code JTC: Device, Microtiter Diluting/Dispensing
JTC is the FDA product code for device, microtiter diluting/dispensing. It is a Class I device, regulated under 21 CFR 866.2500 and reviewed by the Microbiology panel. FDA has cleared 66 510(k) submissions under JTC, from 25 different applicants. The average 510(k) review took 34 days (median 29). FDA has posted 9 recalls for JTC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Microtiter Diluting/Dispensing |
| Device class | Class I |
| Regulation | 21 CFR 866.2500 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JTC clearance
Top JTC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dynatech Laboratories, Inc. | 12 | 1989-10-17 |
| Dynatech Corp. | 6 | 1982-04-14 |
| Flow Laboratories, Inc. | 5 | 1986-06-05 |
| Corning Costar Corp. | 5 | 1982-12-03 |
| Genetic Systems Corp. | 4 | 1989-05-01 |
20 more applicants have JTC clearances. See the full list in Caduvo.
Most recent JTC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924907 | Packard Instrument Co., Inc. | FILTERMATE UNIVERSAL HARVESTER | 1992-12-01 | 63 |
| K901808 | Packard Instrument Co., Inc. | MICROMATE 196 MODEL A961960 | 1990-06-20 | 61 |
| K894645 | Dynatech Laboratories, Inc. | IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM | 1989-10-17 | 85 |
| K892369 | Hamilton Co. | MULTI-PROBE HEAD PLUS | 1989-06-02 | 57 |
| K891768 | Genetic Systems Corp. | GENETIC SYSTEMS MICROPLATE WASHER | 1989-05-01 | 38 |
Recalls for JTC devices
9 product recalls in 8 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-03-22.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code JTC?
JTC is the FDA product code for device, microtiter diluting/dispensing. It is a Class I device, regulated under 21 CFR 866.2500 and reviewed by the Microbiology panel.
What device class is JTC?
Class I, regulation 21 CFR 866.2500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JTC?
Across 66 cleared submissions the average was 34 days from receipt to decision (median 29).
Which companies have the most JTC clearances?
Dynatech Laboratories, Inc. (12); Dynatech Corp. (6); Flow Laboratories, Inc. (5); Corning Costar Corp. (5); Genetic Systems Corp. (4).
Have JTC devices been recalled?
Yes: 9 product recalls across 8 recall events; the most recent began 2023-03-22.
Next steps
- Run an FDA pathway report with predicate devices for product code JTC
- Run a recall and safety report across every JTC manufacturer
- Watch product code JTC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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