Clear Porous Plastic-Hypoallergenic
FDA 510(k) K840948 · Gainor Medical
510(k) numberK840948
Submission
- Device name
- Clear Porous Plastic-Hypoallergenic
- Applicant
- Gainor Medical
- Received
- July 6, 1984
- Decision date
- August 14, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKX – Instrument, Automated Platelet Counting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
Other 510(k)s with product code GKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K014203 | Abx Micros 60 Hematology AnalyzerGKX · Traditional | Abx Diagnostics | 02/28/2002SE |
More from Abx Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K850100 | Blood LancetFMK · Traditional | 01/29/1987SE |
| K850150 | Ulster Scientific, Inc. Autolet Lancets/Gainor MedFMK · Traditional | 02/21/1985SE |
| K844306 | Gainor Medical SyringeFMF · Traditional | 11/30/1984SE |
| K844305 | Gainor Medical Flowmax NeedlesFMI · Traditional | 11/30/1984SE |
| K840951 | First Aid BandageKGX · Traditional | 10/31/1984SE |
| K840950 | Zinc Oxide TapeKGX · Traditional | 10/31/1984SE |
| K840945 | Skin ClosureFPX · Traditional | 10/31/1984SE |
| K840949 | Clear Plastic-HypoallergenicKGX · Traditional | 08/17/1984SE |
| K840947 | Cloth-HypoallergenicKGX · Traditional | 08/17/1984SE |
| K840946 | Microporous HypoallergenicKGW · Traditional | 08/17/1984SE |
Questions and answers
When was Clear Porous Plastic-Hypoallergenic cleared by the FDA?
Clear Porous Plastic-Hypoallergenic (K840948) received a 510(k) decision of Substantially Equivalent on August 14, 1984, 39 days after the submission was received.
What is the product code of K840948?
The FDA product code is GKX – Instrument, Automated Platelet Counting, a Class II (moderate risk) device regulated under 21 CFR 864.5200.