FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET
K Number: K012541
·
Decision Sep 4, 2001
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
149
Applicant Total
13
Review Days
28
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Basic Information
- Device Name
- MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET
- K Number
- K012541
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Branan Medical Corp.
- Date Received
- August 7, 2001
- Decision Date
- September 4, 2001
- Product Code
- LDJ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | FDA class 2 | Clinical Toxicology |
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Other Clearances by Branan Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122633 | TOXCUP DRUG SCREEN CUP | Feb 7, 2013 | Substantially Equivalent |
| K122752 | FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD | Jan 30, 2013 | Substantially Equivalent |
| K040203 | MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 | Mar 25, 2004 | Substantially Equivalent |
| K032057 | TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC | Aug 21, 2003 | Substantially Equivalent |
| K030113 | MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 | Jul 2, 2003 | Substantially Equivalent |
| K023489 | QUICKTOX MULTIPLE DRUG DIPCARD | Dec 16, 2002 | Substantially Equivalent |
| K022355 | QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 | Jul 30, 2002 | Substantially Equivalent |
| K013124 | MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP | Nov 7, 2001 | Substantially Equivalent |
| K010734 | BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 | Jul 30, 2001 | Substantially Equivalent |
| K004034 | MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 | Mar 8, 2001 | Substantially Equivalent |