The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Legionella Igg/igm Elisa Test System.
| Device ID | K963318 |
| 510k Number | K963318 |
| Device Name: | LEGIONELLA IGG/IGM ELISA TEST SYSTEM |
| Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Applicant | ARMKEL, LLC. 1306F BAILES LN. Frederick, MD 21701 |
| Contact | William L Boteler Jr. |
| Correspondent | William L Boteler Jr. ARMKEL, LLC. 1306F BAILES LN. Frederick, MD 21701 |
| Product Code | LHL |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-23 |
| Decision Date | 1997-03-03 |
| Summary: | summary |