510(k) K823111
- Device
- NYSTYMOGRAPH ACCESS
- Applicant
- KELLEHER CORP.
- 510(k) number
- K823111
- Product code
- GNN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-11-22
- Date received
- 1982-10-25
- Regulation
- 866.3145
- Classification name
- Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6
- Medical specialty
- Microbiology
- 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#
- 1419968
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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