FDA product code CHJ: Mercuric Thiocyanate, Colorimetry, Chloride
CHJ is the FDA product code for mercuric thiocyanate, colorimetry, chloride. It is a Class II device, regulated under 21 CFR 862.1170 and reviewed by the Clinical Chemistry panel. FDA has cleared 53 510(k) submissions under CHJ, from 40 different applicants. The average 510(k) review took 62 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Mercuric Thiocyanate, Colorimetry, Chloride |
| Device class | Class II |
| Regulation | 21 CFR 862.1170 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CHJ clearance
Top CHJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Corp. | 6 | 1993-11-05 |
| Technicon Instruments Corp. | 3 | 1989-07-20 |
| Catachem, Inc. | 2 | 1995-02-22 |
| Roche Diagnostic Systems, Inc. | 2 | 1988-12-09 |
| Diagnostic Chemicals, Ltd. (Usa) | 2 | 1988-04-18 |
35 more applicants have CHJ clearances. See the full list in Caduvo.
Most recent CHJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010670 | Abaxis, Inc. | PICCOLO CHLORIDE TEST SYSTEM | 2001-04-26 | 51 |
| K945408 | Catachem, Inc. | 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER | 1995-02-22 | 111 |
| K943006 | Prisma Systems | CHLORIDE QVET | 1994-12-07 | 167 |
| K934136 | Olympus Corp. | OLYMPUS CHLORIDE REAGENT, MODIFICATION | 1993-11-05 | 78 |
| K932528 | Olympus Corp. | OLYMPUS CHLORID REAGENT, MODIFIED | 1993-09-17 | 148 |
Recalls for CHJ devices
openFDA lists no recalls for product code CHJ.
Frequently asked questions
What is FDA product code CHJ?
CHJ is the FDA product code for mercuric thiocyanate, colorimetry, chloride. It is a Class II device, regulated under 21 CFR 862.1170 and reviewed by the Clinical Chemistry panel.
What device class is CHJ?
Class II, regulation 21 CFR 862.1170. Typical premarket route: 510(k).
How long does a 510(k) take for product code CHJ?
Across 53 cleared submissions the average was 62 days from receipt to decision (median 52).
Which companies have the most CHJ clearances?
Olympus Corp. (6); Technicon Instruments Corp. (3); Catachem, Inc. (2); Roche Diagnostic Systems, Inc. (2); Diagnostic Chemicals, Ltd. (Usa) (2).
Next steps
- Run an FDA pathway report with predicate devices for product code CHJ
- Run a recall and safety report across every CHJ manufacturer
- Watch product code CHJ 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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