510(k) K014203
- Device
- ABX MICROS 60 HEMATOLOGY ANALYZER
- Applicant
- ABX DIAGNOSTICS
- 510(k) number
- K014203
- Product code
- GKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-28
- Date received
- 2001-12-21
- Regulation
- 864.5200
- Classification name
- Instrument, Automated Platelet Counting
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOM M PHILLIPS
- Address
- 34 Bunsen Dr. Irvine CA US 92618 92618
Source Documents#
Other 510(k) Records For Product Code GKX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K840948 | CLEAR POROUS PLASTIC-HYPOALLERGENIC | Gainor Medical | 1984-08-14 |
Legacy Summary#
summary
FDA Review#
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