The following data is part of a premarket notification filed by Remel Co. with the FDA for Selective Rapid Urea.
Device ID | K883641 |
510k Number | K883641 |
Device Name: | SELECTIVE RAPID UREA |
Classification | Helicobacter Pylori |
Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Contact | Brenda Henry |
Correspondent | Brenda Henry REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Product Code | LYR |
CFR Regulation Number | 866.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-25 |
Decision Date | 1989-05-04 |