510(k) K770216
- Device
- VIRAL ANTISERA, FLUORESCEIN LABELED
- Applicant
- Flow Laboratories, Inc.
- 510(k) number
- K770216
- Product code
- GRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-03-01
- Date received
- 1977-02-02
- Regulation
- 866.3380
- Classification name
- Antiserum, Fluorescent, Mumps Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1419968
- 1181055
- 3004973408
Source Documents#
510(k) summary PDF not indicated by FDA