The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Immunocard Stat! E. Coli O157 Plus.
Device ID | K023599 |
510k Number | K023599 |
Device Name: | IMMUNOCARD STAT! E. COLI O157 PLUS |
Classification | Antigens, All Types, Escherichia Coli |
Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
Contact | Susan Rolih |
Correspondent | Susan Rolih MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
Product Code | GMZ |
CFR Regulation Number | 866.3255 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-28 |
Decision Date | 2003-01-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840733101816 | K023599 | 000 |