FDA product code KEM: Agent, Clearing
KEM is the FDA product code for agent, clearing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 15 510(k) submissions under KEM, from 9 different applicants. The average 510(k) review took 27 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Agent, Clearing |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KEM clearance
Top KEM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Richard-Allan Medical Ind., Inc. | 5 | 1983-08-12 |
| Anatech, Ltd. | 2 | 1988-04-05 |
| Lerner Laboratories, Inc. | 2 | 1985-10-22 |
| Chem Pharm, Inc. | 1 | 1987-12-04 |
| Helena Laboratories | 1 | 1986-05-06 |
4 more applicants have KEM clearances. See the full list in Caduvo.
Most recent KEM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881282 | Anatech, Ltd. | XYLENE | 1988-04-05 | 11 |
| K874461 | Chem Pharm, Inc. | HEMO-SOL | 1987-12-04 | 36 |
| K861490 | Helena Laboratories | PERMACLEAR SOLUTION CAT. NO. 4950 | 1986-05-06 | 14 |
| K855109 | Surgipath Medical Industries, Inc. | CLEARENE, CLEARING AGENT | 1986-01-07 | 15 |
| K853694 | Lerner Laboratories, Inc. | XYLENE SUBSTITUTE | 1985-10-22 | 48 |
Recalls for KEM devices
openFDA lists no recalls for product code KEM.
Frequently asked questions
What is FDA product code KEM?
KEM is the FDA product code for agent, clearing. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is KEM?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KEM?
Across 15 cleared submissions the average was 27 days from receipt to decision (median 21).
Which companies have the most KEM clearances?
Richard-Allan Medical Ind., Inc. (5); Anatech, Ltd. (2); Lerner Laboratories, Inc. (2); Chem Pharm, Inc. (1); Helena Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KEM
- Run a recall and safety report across every KEM manufacturer
- Watch product code KEM 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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