FDA product code JSY: Kit, Identification, Mycobacteria
JSY is the FDA product code for kit, identification, mycobacteria. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 5 510(k) submissions under JSY, from 3 different applicants. The average 510(k) review took 170 days (median 259). FDA has posted 1 recall for JSY devices.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Identification, Mycobacteria |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JSY clearance
Top JSY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dynagen, Inc. | 3 | 1995-03-13 |
| Alpha-Tec Systems, Inc. | 1 | 1988-03-24 |
| Analytical Products, Inc. | 1 | 1983-03-24 |
Most recent JSY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943050 | Dynagen, Inc. | MYCOAKT M KANSASII CULTURE ID KIT | 1995-03-13 | 259 |
| K943051 | Dynagen, Inc. | MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT | 1995-03-13 | 259 |
| K943049 | Dynagen, Inc. | MYCOAKT M. AVIUM CULTURE ID KIT | 1995-03-13 | 259 |
| K880990 | Alpha-Tec Systems, Inc. | ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION | 1988-03-24 | 16 |
| K830211 | Analytical Products, Inc. | API TB-IDENT* | 1983-03-24 | 59 |
Recalls for JSY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-05-06.
Frequently asked questions
What is FDA product code JSY?
JSY is the FDA product code for kit, identification, mycobacteria. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JSY?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSY?
Across 5 cleared submissions the average was 170 days from receipt to decision (median 259).
Which companies have the most JSY clearances?
Dynagen, Inc. (3); Alpha-Tec Systems, Inc. (1); Analytical Products, Inc. (1).
Have JSY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-05-06.
Next steps
- Run an FDA pathway report with predicate devices for product code JSY
- Run a recall and safety report across every JSY manufacturer
- Watch product code JSY 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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