510(k) K781727
- Device
- CHANGE IN STERILIZATION PROCEDURE
- Applicant
- ABSORBENT COTTON CO., INC.
- 510(k) number
- K781727
- Product code
- GOY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-12-04
- Date received
- 1978-10-11
- Regulation
- 866.3065
- Classification name
- Antisera, Agglutinating, B. Pertussis, All
- Medical specialty
- Microbiology
- Review panel
- Clinical Chemistry
- 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#
- 1025402
- 3003750284
- 1119779
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