MORPHINE ROCHE (R) EIA TEST— 510(k) K864168
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K864168 for MORPHINE ROCHE (R) EIA TEST, Substantially Equivalent on 1987-03-16. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code DOE
- Device class
- Class 2
- Regulation
- 21 CFR 862.3640
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nutley, NJ, US
Recent devices under product code DOE
view all- K010079 — INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
- K010080 — INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
- K011011 — LIVESURE MORPHINE SCREEN TEST
- K002418 — BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D
- K951319 — ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION
More clearances from Roche Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.