510(k) K840948
- Device
- CLEAR POROUS PLASTIC-HYPOALLERGENIC
- Applicant
- GAINOR MEDICAL
- 510(k) number
- K840948
- Product code
- GKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-08-14
- Date received
- 1984-07-06
- Regulation
- 864.5200
- Classification name
- Instrument, Automated Platelet Counting
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- MD US
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GKX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K014203 | ABX MICROS 60 HEMATOLOGY ANALYZER | Abx Diagnostics | 2002-02-28 |
Legacy Summary#
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FDA Review#
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