The following data is part of a premarket notification filed by Scott Laboratories, Inc. with the FDA for Anaswab.
Device ID | K780159 |
510k Number | K780159 |
Device Name: | ANASWAB |
Classification | Transport Systems, Anaerobic |
Applicant | SCOTT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTX |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-01-30 |
Decision Date | 1978-02-13 |