FDA product code KHM: Nephelometric, Amylase
KHM is the FDA product code for nephelometric, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel. FDA has cleared 6 510(k) submissions under KHM, from 6 different applicants. The average 510(k) review took 44 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Nephelometric, Amylase |
| Device class | Class II |
| Regulation | 21 CFR 862.1070 |
| 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 KHM clearance
Top KHM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hi Chem, Inc. | 1 | 1983-06-30 |
| Pointe Scientific, Inc., | 1 | 1981-10-06 |
| Bioscientific | 1 | 1981-09-09 |
| Stat Engineering | 1 | 1980-06-09 |
| Alta Diagnostics, Inc. | 1 | 1979-07-17 |
1 more applicants have KHM clearances. See the full list in Caduvo.
Most recent KHM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831295 | Hi Chem, Inc. | AMYLASE REAGENT #88129 | 1983-06-30 | 71 |
| K812699 | Pointe Scientific, Inc., | AMYLASE | 1981-10-06 | 14 |
| K812447 | Bioscientific | AMYLASE REAGENT KIT | 1981-09-09 | 12 |
| K801096 | Stat Engineering | PERKIN ELMER MODEL 91 AMYLASE REAGENT | 1980-06-09 | 31 |
| K790797 | Alta Diagnostics, Inc. | AMYLASE REAGENT SET | 1979-07-17 | 84 |
Recalls for KHM devices
openFDA lists no recalls for product code KHM.
Frequently asked questions
What is FDA product code KHM?
KHM is the FDA product code for nephelometric, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel.
What device class is KHM?
Class II, regulation 21 CFR 862.1070. Typical premarket route: 510(k).
How long does a 510(k) take for product code KHM?
Across 6 cleared submissions the average was 44 days from receipt to decision (median 43).
Which companies have the most KHM clearances?
Hi Chem, Inc. (1); Pointe Scientific, Inc., (1); Bioscientific (1); Stat Engineering (1); Alta Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KHM
- Run a recall and safety report across every KHM manufacturer
- Watch product code KHM 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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