Submission Details
| 510(k) Number | K002375 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 04, 2000 |
| Decision Date | January 26, 2001 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
Jan 2001
Decision
175d
Days
Class 2
Risk
About This 510(k) Submission
K002375 is an FDA 510(k) clearance for the STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on January 26, 2001, 175 days after receiving the submission on August 4, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.
Device Classification
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3870 |
Manufacturer
Similar Devices — LDJ Enzyme Immunoassay, Cannabinoids
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