Submission Details
| 510(k) Number | K970149 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 15, 1997 |
| Decision Date | June 18, 1997 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
LEGIONELLA ELISA TEST SYSTEM
Jun 1997
Decision
154d
Days
Class 2
Risk
About This 510(k) Submission
K970149 is an FDA 510(k) clearance for the LEGIONELLA ELISA TEST SYSTEM, a Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II — Special Controls, product code LHL), submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on June 18, 1997, 154 days after receiving the submission on January 15, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.
Device Classification
| Product Code | LHL — Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3300 |
Manufacturer
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