The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Pylori Stat Test Kit.
| Device ID | K904738 |
| 510k Number | K904738 |
| Device Name: | PYLORI STAT 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 | 1990-10-18 |
| Decision Date | 1991-05-07 |