FDA product code CHI: Lipase-Esterase, Enzymatic, Photometric, Lipase
CHI is the FDA product code for lipase-esterase, enzymatic, photometric, lipase. It is a Class I device, regulated under 21 CFR 862.1465 and reviewed by the Clinical Chemistry panel. FDA has cleared 20 510(k) submissions under CHI, from 16 different applicants. The average 510(k) review took 98 days (median 70). FDA has posted 22 recalls for CHI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lipase-Esterase, Enzymatic, Photometric, Lipase |
| Device class | Class I |
| Regulation | 21 CFR 862.1465 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CHI clearance
Top CHI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 2 | 1997-06-04 |
| Nuclear Diagnostics, Inc. | 2 | 1994-02-25 |
| Wako Chemicals USA, Inc. | 2 | 1992-07-21 |
| Eastman Kodak Company | 2 | 1988-02-24 |
| Equal Diagnostics, Inc. | 1 | 1996-07-19 |
11 more applicants have CHI clearances. See the full list in Caduvo.
Most recent CHI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970905 | Beckman Instruments, Inc. | SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT | 1997-06-04 | 84 |
| K961179 | Equal Diagnostics, Inc. | SENTINEL LIPASE LIQUID MODEL 17.401B | 1996-07-19 | 115 |
| K952180 | Beckman Instruments, Inc. | CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS | 1995-08-17 | 100 |
| K952816 | Dupont Medical Products | LIPASE FLEX REAGENT CARTRIDGE | 1995-07-20 | 30 |
| K952647 | Instrumentation Laboratory CO | IL TEST LIPASE | 1995-07-20 | 41 |
Recalls for CHI devices
22 product recalls in 16 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-09-12.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 3 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code CHI?
CHI is the FDA product code for lipase-esterase, enzymatic, photometric, lipase. It is a Class I device, regulated under 21 CFR 862.1465 and reviewed by the Clinical Chemistry panel.
What device class is CHI?
Class I, regulation 21 CFR 862.1465. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CHI?
Across 20 cleared submissions the average was 98 days from receipt to decision (median 70).
Which companies have the most CHI clearances?
Beckman Instruments, Inc. (2); Nuclear Diagnostics, Inc. (2); Wako Chemicals USA, Inc. (2); Eastman Kodak Company (2); Equal Diagnostics, Inc. (1).
Have CHI devices been recalled?
Yes: 22 product recalls across 16 recall events; the most recent began 2023-09-12.
Next steps
- Run an FDA pathway report with predicate devices for product code CHI
- Run a recall and safety report across every CHI manufacturer
- Watch product code CHI 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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