Submission Details
| 510(k) Number | K861460 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 1986 |
| Decision Date | May 02, 1986 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
Cleared
Traditional
SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101
May 1986
Decision
14d
Days
Class 2
Risk
About This 510(k) Submission
K861460 is an FDA 510(k) clearance for the SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101, a Antisera, If, Toxoplasma Gondii (Class II — Special Controls, product code LJK), submitted by Widran Urological Group, Ltd. (Chicago, US). The FDA issued a Cleared decision on May 2, 1986, 14 days after receiving the submission on April 18, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.
Device Classification
| Product Code | LJK — Antisera, If, Toxoplasma Gondii |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3780 |
Manufacturer
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