The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Campylobacter Supplement-blaser/wang.
Device ID | K850307 |
510k Number | K850307 |
Device Name: | CAMPYLOBACTER SUPPLEMENT-BLASER/WANG |
Classification | Supplement, Culture Media |
Applicant | PRO-LAB, INC. 76 GLENGARRY AVENUE TORONTO Ontario Canada M5m 1c9, CA |
Contact | Lynn Rae |
Correspondent | Lynn Rae PRO-LAB, INC. 76 GLENGARRY AVENUE TORONTO Ontario Canada M5m 1c9, CA |
Product Code | JSK |
CFR Regulation Number | 866.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-22 |
Decision Date | 1985-03-20 |