The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Stat Test Kit For Eb-vca Igg Antibody.
Device ID | K891086 |
510k Number | K891086 |
Device Name: | STAT TEST KIT FOR EB-VCA IGG ANTIBODY |
Classification | Epstein-barr Virus, Other |
Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
Contact | Leif E Olsen |
Correspondent | Leif E Olsen WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
Product Code | LSE |
CFR Regulation Number | 866.3235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-01 |
Decision Date | 1989-05-10 |