510(k) K810684
- Device
- HEMOCOLOR STAIN SET
- Applicant
- HARLECO
- 510(k) number
- K810684
- Product code
- ICC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-04-08
- Date received
- 1981-03-13
- Regulation
- 864.1850
- Classification name
- Eosin B
- Medical specialty
- Hematology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9610140
- 1000138378
- 1937990
- 3009432145
- 1045125
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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