The following data is part of a premarket notification filed by Icl Scientific with the FDA for Rid Systems - Alph-1-acid Glycoprotein.
Device ID | K792314 |
510k Number | K792314 |
Device Name: | RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN |
Classification | Sigmoidoscope And Accessories, Flexible/rigid |
Applicant | ICL SCIENTIFIC 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FAM |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-16 |
Decision Date | 1979-12-06 |