510(k) K771101
- Device
- HEMOGLOBIN ANALYZER & PERFORM. CHECK SET
- Applicant
- The Dow Chemical Co.
- 510(k) number
- K771101
- Product code
- GIG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-21
- Date received
- 1977-06-20
- Regulation
- 864.7500
- Classification name
- Hemoglobinometer
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3011979858
- 3004193489
- 1219029
- 3004493545
Source Documents#
510(k) summary PDF not indicated by FDA