The following data is part of a premarket notification filed by Springwood Microbiologicals with the FDA for Direct Fa Conjugate For Legionella Sp.
Device ID | K813339 |
510k Number | K813339 |
Device Name: | DIRECT FA CONJUGATE FOR LEGIONELLA SP |
Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
Applicant | SPRINGWOOD MICROBIOLOGICALS 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | LHL |
CFR Regulation Number | 866.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-24 |
Decision Date | 1981-12-18 |