Branan Medical Corp.
Irvine, CA, US
Branan Medical Corp. appears in FDA device records in Irvine, CA. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Branan Medical Corp. between 2000 and 2013. The busiest year on record is 2000, with 11. The most recent is 2013, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 11 |
| 2001 | 4 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2008 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K122633 | TOXCUP DRUG SCREEN CUP | LDJ | Substantially Equivalent | |
| K122752 | FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD | JXN | Substantially Equivalent | |
| K103227 | ORATECT ORAL FLUID DRUG SCREEN DEVICES | DIO | Substantially Equivalent | |
| K082508 | FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD | DJG | Substantially Equivalent | |
| K040203 | MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 | DKZ | Substantially Equivalent | |
| K032057 | TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC | DIO | Substantially Equivalent | |
| K030113 | MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 | DJG | Substantially Equivalent | |
| K023489 | QUICKTOX MULTIPLE DRUG DIPCARD | DIO | Substantially Equivalent | |
| K022355 | QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 | DIO | Substantially Equivalent | |
| K013124 | MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP | DJJ | Substantially Equivalent | |
| K012541 | MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET | LDJ | Substantially Equivalent | |
| K010734 | BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 | MLK | Substantially Equivalent | |
| K004034 | MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 | DKZ | Substantially Equivalent | |
| K002342 | BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST | JXM | Substantially Equivalent | |
| K002268 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST | DJG | Substantially Equivalent | |
| K002265 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST | DJC | Substantially Equivalent | |
| K002264 | BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST | DIO | Substantially Equivalent | |
| K002263 | BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST | LDJ | Substantially Equivalent | |
| K002587 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST | DJC | Substantially Equivalent | |
| K002418 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D | DOE | Substantially Equivalent | |
| K002417 | BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D | DJR | Substantially Equivalent | |
| K002337 | BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST | DIS | Substantially Equivalent | |
| K002272 | BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D | LCM | Substantially Equivalent | |
| K002266 | BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST | DKZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- DJJFluorometry, Morphine
- DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
- DJCThin Layer Chromatography, Methamphetamine
- MLKThin Layer Chromatography, Tricyclic Antidepressant Drugs
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2311-2016 | AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetamine Amphetamine 1000 ng/mL AMP Methamphetamine Methamphetamine 1000 ng/mL MET Opiates Morphine 2000 ng/mL OPI Opiates300 Morphine 300 ng/ml OPI300 Phencyclidine Phencyclidine 25 ng/mL PCP Barbiturates Secobarbital 300 ng/mL BAR Benzodiazepines Oxazepam 300 ng/mL BZD Methadone Methadone 300 ng/mL MTD Oxycodone Oxycodone 100 ng/mL OXY MDMA MDMA 500 ng/mL MDMA Tricyclic Antidepressants Nortriptyline 1000 ng/mL TCA | Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error. | Class III | Terminated | |
| Z-1508-2014 | ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only. | May be labeled with incorrect result interpretation graphics on the ToxCup lid label. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain