The following data is part of a premarket notification filed by Guardian Scientific, Corp. with the FDA for Quix Rapid E. Coli O157 Strip Test.
Device ID | K972156 |
510k Number | K972156 |
Device Name: | QUIX RAPID E. COLI O157 STRIP TEST |
Classification | Antigens, All Types, Escherichia Coli |
Applicant | GUARDIAN SCIENTIFIC, CORP. 8990-E ROUTE 108 Columbia, MD 21045 |
Contact | Kathryn B Powers |
Correspondent | Kathryn B Powers GUARDIAN SCIENTIFIC, CORP. 8990-E ROUTE 108 Columbia, MD 21045 |
Product Code | GMZ |
CFR Regulation Number | 866.3255 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-09 |
Decision Date | 1997-10-16 |