The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Pylori-g Fiax Test Kit.
Device ID | K905468 |
510k Number | K905468 |
Device Name: | PYLORI-G FIAX TEST KIT |
Classification | Helicobacter Pylori |
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 | LYR |
CFR Regulation Number | 866.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-06 |
Decision Date | 1991-05-07 |