FDA product code KEQ: Media, Mounting, Water Soluble
KEQ is the FDA product code for media, mounting, water soluble. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 7 510(k) submissions under KEQ, from 4 different applicants. The average 510(k) review took 25 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Media, Mounting, Water Soluble |
| 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 KEQ clearance
Top KEQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 3 | 1980-01-24 |
| Marion Laboratories, Inc. | 2 | 1978-11-22 |
| Surgipath Medical Industries, Inc. | 1 | 1983-03-31 |
| Flow Laboratories, Inc. | 1 | 1978-08-21 |
Most recent KEQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830515 | Surgipath Medical Industries, Inc. | SCOTTS TAP WATER SUBSTITUTE CONCENTRATE | 1983-03-31 | 42 |
| K792703 | Meridian Diagnostics, Inc. | LACTO-PHENOL ANALINE BLUE FLUID | 1980-01-24 | 28 |
| K792709 | Meridian Diagnostics, Inc. | KOH MOUNTING FLUID W/GLYCEROL | 1980-01-24 | 28 |
| K792702 | Meridian Diagnostics, Inc. | VASPAR SEALANT | 1980-01-24 | 28 |
| K781869 | Marion Laboratories, Inc. | DROPPER, CEPTI-SEAL KOH SOLUTION | 1978-11-22 | 19 |
Recalls for KEQ devices
openFDA lists no recalls for product code KEQ.
Frequently asked questions
What is FDA product code KEQ?
KEQ is the FDA product code for media, mounting, water soluble. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is KEQ?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KEQ?
Across 7 cleared submissions the average was 25 days from receipt to decision (median 28).
Which companies have the most KEQ clearances?
Meridian Diagnostics, Inc. (3); Marion Laboratories, Inc. (2); Surgipath Medical Industries, Inc. (1); Flow Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KEQ
- Run a recall and safety report across every KEQ manufacturer
- Watch product code KEQ 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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