FDA product code KIN: Slide Stainer, Contact Type
KIN is the FDA product code for slide stainer, contact type. It is a Class I device, regulated under 21 CFR 864.3800 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under KIN. The average 510(k) review took 50 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Slide Stainer, Contact Type |
| Device class | Class I |
| Regulation | 21 CFR 864.3800 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIN clearance
Top KIN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gamma Biologicals, Inc. | 1 | 1976-08-03 |
Most recent KIN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K760032 | Gamma Biologicals, Inc. | TEST, MONO., DIFFERENTIAL SLIDE | 1976-08-03 | 50 |
Recalls for KIN devices
openFDA lists no recalls for product code KIN.
Frequently asked questions
What is FDA product code KIN?
KIN is the FDA product code for slide stainer, contact type. It is a Class I device, regulated under 21 CFR 864.3800 and reviewed by the Pathology panel.
What device class is KIN?
Class I, regulation 21 CFR 864.3800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIN?
Across 1 cleared submissions the average was 50 days from receipt to decision (median 50).
Which companies have the most KIN clearances?
Gamma Biologicals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KIN
- Run a recall and safety report across every KIN manufacturer
- Watch product code KIN 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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