FDA product code KSG: Media, Potentiating For In Vitro Diagnostic Use
KSG is the FDA product code for media, potentiating for in vitro diagnostic use. It is a Class II device, regulated under 21 CFR 864.9600 and reviewed by the Hematology panel. FDA has cleared 13 510(k) submissions under KSG, from 10 different applicants. The average 510(k) review took 28 days (median 29). FDA has posted 1 recall for KSG devices.
Classification
| Field | Value |
|---|---|
| Device name | Media, Potentiating For In Vitro Diagnostic Use |
| Device class | Class II |
| Regulation | 21 CFR 864.9600 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KSG clearance
Top KSG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biological Corp. of America | 3 | 1981-10-23 |
| Ortho Diagnostics, Inc. | 2 | 1979-10-11 |
| Miles Laboratories, Inc. | 1 | 1980-05-08 |
| Gotham Biologics, Inc. | 1 | 1980-02-13 |
| Hyland Therapeutic Div., Travenol Laboratories | 1 | 1979-06-28 |
5 more applicants have KSG clearances. See the full list in Caduvo.
Most recent KSG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812565 | Biological Corp. of America | ELUTION SOLUTION | 1981-10-23 | 44 |
| K812222 | Biological Corp. of America | EM-X | 1981-09-23 | 47 |
| K800943 | Miles Laboratories, Inc. | PENTEX BOVINE ALBUMIN 30% SOLUTION | 1980-05-08 | 16 |
| K800189 | Gotham Biologics, Inc. | BOVINE ALBUMIN 22% & 30% SOLUTIONS | 1980-02-13 | 15 |
| K791791 | Ortho Diagnostics, Inc. | ORTHO ANTIBODY ENHANCEMENT SOLUTION | 1979-10-11 | 30 |
Recalls for KSG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-10-14.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code KSG?
KSG is the FDA product code for media, potentiating for in vitro diagnostic use. It is a Class II device, regulated under 21 CFR 864.9600 and reviewed by the Hematology panel.
What device class is KSG?
Class II, regulation 21 CFR 864.9600. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KSG?
Across 13 cleared submissions the average was 28 days from receipt to decision (median 29).
Which companies have the most KSG clearances?
Biological Corp. of America (3); Ortho Diagnostics, Inc. (2); Miles Laboratories, Inc. (1); Gotham Biologics, Inc. (1); Hyland Therapeutic Div., Travenol Laboratories (1).
Have KSG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-10-14.
Next steps
- Run an FDA pathway report with predicate devices for product code KSG
- Run a recall and safety report across every KSG manufacturer
- Watch product code KSG 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.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times