510(k) K833708
- Device
- COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE
- Applicant
- WORTHINGTON DIAGNOSTIC SYSTEMS
- 510(k) number
- K833708
- Product code
- LKZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-04
- Date received
- 1983-10-20
- Regulation
- 864.7100
- Classification name
- Red-cell Count By Photometry
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LKZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832771 | ERYTHROCYTE TEST | Bio-Analytics Laboratories, Inc. | 1983-10-28 |
Legacy Summary#
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FDA Review#
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