ABUSCREEN ONLINE TM FOR THC— 510(k) K904996
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K904996 for ABUSCREEN ONLINE TM FOR THC, Substantially Equivalent on 1991-01-11. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LAT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montclair, NJ, US
Recent devices under product code LAT
view all- K011426 — PSYCHEMEDICS RIA CANNABINOID ASSAY
- K961620 — ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100
- K936135 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION
- K914507 — DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE
- K913414 — ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT
More clearances from Roche Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.