510(k) K812013
- Device
- FLUORESCENT ANTIBODY CONJUGATE FOR GP.A
- Applicant
- SPRINGWOOD MICROBIOLOGICALS
- 510(k) number
- K812013
- Product code
- GTX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-07-28
- Date received
- 1981-07-17
- Regulation
- 866.3740
- Classification name
- Antisera, Fluorescent, All Groups, Streptococcus Spp.
- 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
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases