MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET— 510(k) K012541
Substantially EquivalentBranan Medical Corp.
FDA 510(k) clearance K012541 for MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET, Substantially Equivalent on 2001-09-04. Applicant: Branan Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Branan Medical Corp.
- Product code
- Code LDJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Recent devices under product code LDJ
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- K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
- K153741 — CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
More clearances from Branan Medical Corp.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.