The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Legionella Reagens For Direct Fluorescent Antibody.
| Device ID | K921421 |
| 510k Number | K921421 |
| Device Name: | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY |
| Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Applicant | PRO-LAB, INC. 76 GLENGARRY AVENUE TORONTO Ontario Canada M5m 1c9, CA |
| Contact | Joachim Sparkuhl |
| Correspondent | Joachim Sparkuhl PRO-LAB, INC. 76 GLENGARRY AVENUE TORONTO Ontario Canada M5m 1c9, CA |
| Product Code | LHL |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1992-07-28 |