510(k) K761270
- Device
- IMMUNO-TEC II OT AGAROSE PLATE KIT
- Applicant
- Behring Diagnostics, Inc.
- 510(k) number
- K761270
- Product code
- JZP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-30
- Date received
- 1976-12-16
- Regulation
- 866.4600
- Classification name
- Plates, Ouchterlony Agar
- Medical specialty
- Immunology
- Review panel
- Immunology
- 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#
- 1627497
Source Documents#
510(k) summary PDF not indicated by FDA