The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Legionella Immunofluorescent Antibody Test Kit.
Device ID | K852237 |
510k Number | K852237 |
Device Name: | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT |
Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
Applicant | GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
Contact | Monica S Krieger |
Correspondent | Monica S Krieger GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
Product Code | LHL |
CFR Regulation Number | 866.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-22 |
Decision Date | 1985-08-22 |