The following data is part of a premarket notification filed by I.a.f. Production, Inc. with the FDA for Iafp Thioglycollate W/o Indicator W/hemin&vita. K1.
| Device ID | K872678 |
| 510k Number | K872678 |
| Device Name: | IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1 |
| Classification | Culture Media, Enriched |
| 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 | KZI |
| CFR Regulation Number | 866.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-07 |
| Decision Date | 1987-08-07 |