Abx Micros 60 Hematology Analyzer
FDA 510(k) K014203 · Abx Diagnostics
510(k) numberK014203
Submission
- Device name
- Abx Micros 60 Hematology Analyzer
- Applicant
- Abx Diagnostics
Irvine, CA, US - Received
- December 21, 2001
- Decision date
- February 28, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| K840948 | Clear Porous Plastic-HypoallergenicGKX · Traditional | Gainor Medical | 08/14/1984SE |
More from Gainor Medical
| 510(k) | Device | Decision |
|---|---|---|
| K030799 | Micros 60GKZ · Special | 04/08/2003SE |
| K030144 | Modification to Pentra 60 and Pentra 60C+GKZ · Special | 01/31/2003SE |
| K024002 | Pentra 80GKZ · Special | 01/03/2003SE |
| K022200 | Pentra 120/PENTRA 120 Retic Options SPS, Model Pentra 120GKZ · Special | 07/29/2002SE |
| K003677 | Abx Pentra 60C+ Hematology AnalyzerGKZ · Special | 12/26/2000SE |
| K002646 | Abx Micros CRPGKZ · Traditional | 10/26/2000SE |
| K992511 | Abx Pentra 60 Hematology AnalyzerGKZ · Traditional | 10/15/1999SE |
| K991839 | Abx Pentra 120 Retic Automated Hematology AnalyzerGKZ · Traditional | 08/11/1999SE |
| K990311 | Vega Retic Automated Hematology AnalyzerGKZ · Traditional | 03/31/1999SE |
Questions and answers
When was Abx Micros 60 Hematology Analyzer cleared by the FDA?
Abx Micros 60 Hematology Analyzer (K014203) received a 510(k) decision of Substantially Equivalent on February 28, 2002, 69 days after the submission was received.
What is the product code of K014203?
The FDA product code is GKX – Instrument, Automated Platelet Counting, a Class II (moderate risk) device regulated under 21 CFR 864.5200.