SYPH-TRUST

Antigens, Nontreponemal, All

I.A.F. PRODUCTION, INC.

The following data is part of a premarket notification filed by I.a.f. Production, Inc. with the FDA for Syph-trust.

Pre-market Notification Details

• Device ID: K863368
• 510k Number: K863368
• Device Name: SYPH-TRUST
• Classification: Antigens, Nontreponemal, All
• Applicant: I.A.F. PRODUCTION, INC. 527 BOULEVARD DES PRAIRIES P.O. BOX 310, LAVAL Quebec, Canada H7n4z9, CA
• Contact: Francois Morin
• Correspondent: Francois Morin; I.A.F. PRODUCTION, INC. 527 BOULEVARD DES PRAIRIES P.O. BOX 310, LAVAL Quebec, Canada H7n4z9, CA
• Product Code: GMQ
• CFR Regulation Number: 866.3820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-09-03
• Decision Date: 1986-12-12