The following data is part of a premarket notification filed by Pro-lab Diagnostics with the FDA for E.coli 0157 Latex Test.
Device ID | K944421 |
510k Number | K944421 |
Device Name: | E.COLI 0157 LATEX TEST |
Classification | Antigens, All Types, Escherichia Coli |
Applicant | PRO-LAB DIAGNOSTICS 20 MURAL ST. RICHMOND HILL Ontario, CA |
Contact | Lynn Rae |
Correspondent | Lynn Rae PRO-LAB DIAGNOSTICS 20 MURAL ST. RICHMOND HILL Ontario, CA |
Product Code | GMZ |
CFR Regulation Number | 866.3255 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-18 |
Decision Date | 1994-12-15 |