The following data is part of a premarket notification filed by Remel Co. with the FDA for Bacti-swab(tm) Npg.
Device ID | K912832 |
510k Number | K912832 |
Device Name: | BACTI-SWAB(TM) NPG |
Classification | Device, Specimen Collection |
Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Contact | Ann Silvius |
Correspondent | Ann Silvius REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Product Code | LIO |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-26 |
Decision Date | 1991-08-22 |