FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D
K Number: K002272
·
Decision Nov 22, 2000
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
87
Applicant Total
13
Review Days
119
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Basic Information
- Device Name
- BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D
- K Number
- K002272
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Branan Medical Corp.
- Date Received
- July 26, 2000
- Decision Date
- November 22, 2000
- Product Code
- LCM
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | FDA unclassified | Unknown |
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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 |
| K012541 | MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET | Sep 4, 2001 | Substantially Equivalent |
| K010734 | BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 | Jul 30, 2001 | Substantially Equivalent |