The following data is part of a premarket notification filed by I.a.f. Production, Inc. with the FDA for Iafp Sabouraud Dextrose Agar.
Device ID | K872689 |
510k Number | K872689 |
Device Name: | IAFP SABOURAUD DEXTROSE AGAR |
Classification | Culture Media, Selective And Non-differential |
Applicant | I.A.F. PRODUCTION, INC. 527, BOUL. DES PRAIRIES Laval, Que. H7n-423, CA |
Contact | Francois Morin |
Correspondent | Francois Morin I.A.F. PRODUCTION, INC. 527, BOUL. DES PRAIRIES Laval, Que. H7n-423, CA |
Product Code | JSJ |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-07 |
Decision Date | 1987-08-11 |