Product code DKE— Clinical Toxicology
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
- Classification name
- Reagents, Test, Tetrahydrocannabinol
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code DKE
FDA has cleared devices under product code DKE between 1980 and 2000, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2000
- 1999
- 1998
- 1990
- 1988
- 1984
- 1983
- 1980
Top applicants under product code DKE
Recent clearances under product code DKE
- K003687 — VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
- K994405 — INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
- K992068 — STATUS STIK, ACCUSIGN STIK
- K991751 — STATUS CUP ACCUSIGN CUP
- K991078 — ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
- K983147 — ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
- K982211 — PROFILE-II MODEL 600582
- K901694 — SPEC(TM) EXTRACTION CARTRIDGE
- K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN
- K841831 — CANNU-SKREEN-PRELIMINARY
- K831456 — TOXI-LAB CANNABINOID THC SCREEN
- K792282 — DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG
Data sourced from openFDA. This site is unofficial and independent of the FDA.