URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)— 510(k) K933572
Substantially EquivalentImmunalysis Corporation
FDA 510(k) clearance K933572 for URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125), Substantially Equivalent on 1994-04-06. Applicant: Immunalysis Corporation. Device class: 2.
Clearance details
- Applicant
- Immunalysis Corporation
- 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
- Glendale, CA, 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 Immunalysis Corporation
view allData sourced from openFDA. This site is unofficial and independent of the FDA.