510(k) K883683
- Device
- HEMOGLOBIN
- Applicant
- TECH-CO, INC.
- 510(k) number
- K883683
- Product code
- GJZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-06
- Date received
- 1988-08-29
- Regulation
- 864.7500
- Classification name
- Cyanomethemoglobin Reagent And Standard Solution
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHEN, PH.D.
- Address
- 24111 Beverly Oak Park MI US 48237 48237
FDA Registration Numbers#
- 1832216
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GJZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881242 | CELL-DYN RAPID-LYSE AND HEMOGLOBLIN | Abbott Diagnostics | 1988-04-21 |
Legacy Summary#
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FDA Review#
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