FDA product code JIH: Flame Photometry, Lithium
JIH is the FDA product code for flame photometry, lithium. It is a Class II device, regulated under 21 CFR 862.3560 and reviewed by the Clinical Toxicology panel. FDA has cleared 12 510(k) submissions under JIH, from 11 different applicants. The average 510(k) review took 100 days (median 90). FDA has posted 2 recalls for JIH devices.
Classification
| Field | Value |
|---|---|
| Device name | Flame Photometry, Lithium |
| Device class | Class II |
| Regulation | 21 CFR 862.3560 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JIH clearance
Top JIH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 2 | 1994-04-25 |
| Akers Biosciences, Inc. | 1 | 2005-03-04 |
| Akers Laboratories, Inc. | 1 | 2003-12-19 |
| Dade Behring, Inc. | 1 | 2001-06-07 |
| Ciba Corning Diagnostics Corp. | 1 | 1992-07-30 |
6 more applicants have JIH clearances. See the full list in Caduvo.
Most recent JIH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050338 | Akers Biosciences, Inc. | MODIFICATION TO: INSTAREAD LITHIUM SYSTEM | 2005-03-04 | 21 |
| K031579 | Akers Laboratories, Inc. | INSTAREAD LITHIUM SYSTEM | 2003-12-19 | 213 |
| K011033 | Dade Behring, Inc. | DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 | 2001-06-07 | 63 |
| K934106 | Eastman Kodak Company | KODAK EKTACHEM DTSC II SLIDES (LI) | 1994-04-25 | 245 |
| K924488 | Eastman Kodak Company | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) | 1993-01-26 | 145 |
Recalls for JIH devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-02-01.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code JIH?
JIH is the FDA product code for flame photometry, lithium. It is a Class II device, regulated under 21 CFR 862.3560 and reviewed by the Clinical Toxicology panel.
What device class is JIH?
Class II, regulation 21 CFR 862.3560. Typical premarket route: 510(k).
How long does a 510(k) take for product code JIH?
Across 12 cleared submissions the average was 100 days from receipt to decision (median 90).
Which companies have the most JIH clearances?
Eastman Kodak Company (2); Akers Biosciences, Inc. (1); Akers Laboratories, Inc. (1); Dade Behring, Inc. (1); Ciba Corning Diagnostics Corp. (1).
Have JIH devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-02-01.
Next steps
- Run an FDA pathway report with predicate devices for product code JIH
- Run a recall and safety report across every JIH manufacturer
- Watch product code JIH 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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