Submission Details
| 510(k) Number | K863475 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 09, 1986 |
| Decision Date | November 05, 1986 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
Cleared
Traditional
THEOFAST(TM) TEST PACKAGE
Nov 1986
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K863475 is an FDA 510(k) clearance for the THEOFAST(TM) TEST PACKAGE, a Fluorescent Immunoassay, Theophylline (Class II — Special Controls, product code LER), submitted by 3M Company (Mountain View, US). The FDA issued a Cleared decision on November 5, 1986, 57 days after receiving the submission on September 9, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3880.
Device Classification
| Product Code | LER — Fluorescent Immunoassay, Theophylline |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3880 |
Manufacturer
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