QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61— 510(k) K022355
Substantially EquivalentBranan Medical Corp.
FDA 510(k) clearance K022355 for QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61, Substantially Equivalent on 2002-07-30. Applicant: Branan Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Branan Medical Corp.
- Product code
- Code DIO
- Device class
- Class 2
- Regulation
- 21 CFR 862.3250
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Recent devices under product code DIO
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view all- K122633 — TOXCUP DRUG SCREEN CUP
- K122752 — FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD
- K040203 — MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22
- K032057 — TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
- K030113 — MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23
Recalls naming K022355
K-number listed on FDA's recall record- Z-3034-2020 — Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect¿ II Drug Screen Dipstick Test, 4 Drug Detection: THC50+COC300+OPI300+BZO300", MF20/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: MTD300", MF21/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: TCA1000, MF23/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF23/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF18/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BZO300, MF18/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BZO300", QF12/ "Fastect¿ II Drug Screen Dipstick Test 4 Drug Detection: THC50+COC300+OPI300+MET500", MF10/ "Fastect¿ II Drug Screen Dipstick Test THC50", MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF16 /"Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: MET500", MF23 /"Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF14/ "Fastect¿ II Drug Screen Dipstick Test AMP1000", MF11/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: COC300", MF23 / Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF23/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100"
- Z-0692-2020 — QuickTox 5 Panel Drug Screen DipCard
- Z-1542-2018 — Alere iScreen Dx Urine Drug Screen Card
- Z-3084-2017 — Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022355.
Data sourced from openFDA. This site is unofficial and independent of the FDA.