Submission Details
| 510(k) Number | K983701 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 21, 1998 |
| Decision Date | December 11, 1998 |
| Days to Decision | 51 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Special
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
Dec 1998
Decision
51d
Days
Class 2
Risk
About This 510(k) Submission
K983701 is an FDA 510(k) clearance for the MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on December 11, 1998, 51 days after receiving the submission on October 21, 1998. 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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