Company ยท US
Branan Medical Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2013. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 7 |
| DJG | Enzyme Immunoassay, Opiates | 3 |
| DKZ | Enzyme Immunoassay, Amphetamine | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 |
| DJC | Thin Layer Chromatography, Methamphetamine | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 |
| DJJ | Fluorometry, Morphine | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 |
| DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 |
| JXN | Enzyme Immunoassay, Propoxyphene | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 |
| MLK | Thin Layer Chromatography, Tricyclic Antidepressant Drugs | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 7, 2013 | K122633 | TOXCUP DRUG SCREEN CUP Branan Medical Corp. | LDJ |
| Jan 30, 2013 | K122752 | FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD Branan Medical Corp. | JXN |
| Apr 11, 2012 | K103227 | ORATECT ORAL FLUID DRUG SCREEN DEVICES Branan Medical Corporation | DIO |
| Nov 21, 2008 | K082508 | FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD Branan Medical Corporation | DJG |
| Mar 25, 2004 | K040203 | MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 Branan Medical Corp. | DKZ |
| Aug 21, 2003 | K032057 | TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC Branan Medical Corp. | DIO |
| Jul 2, 2003 | K030113 | MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 Branan Medical Corp. | DJG |
| Dec 16, 2002 | K023489 | QUICKTOX MULTIPLE DRUG DIPCARD Branan Medical Corp. | DIO |
| Jul 30, 2002 | K022355 | QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 Branan Medical Corp. | DIO |
| Nov 7, 2001 | K013124 | MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP Branan Medical Corp. | DJJ |
| Sep 4, 2001 | K012541 | MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET Branan Medical Corp. | LDJ |
| Jul 30, 2001 | K010734 | BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 Branan Medical Corp. | MLK |
| Mar 8, 2001 | K004034 | MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 Branan Medical Corp. | DKZ |
| Nov 27, 2000 | K002342 | BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST Branan Medical Corporation | JXM |
| Nov 27, 2000 | K002268 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST Branan Medical Corporation | DJG |
| Nov 27, 2000 | K002265 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST Branan Medical Corporation | DJC |
| Nov 27, 2000 | K002264 | BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST Branan Medical Corporation | DIO |
| Nov 27, 2000 | K002263 | BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST Branan Medical Corp. | LDJ |
| Nov 22, 2000 | K002587 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST Branan Medical Corporation | DJC |
| Nov 22, 2000 | K002418 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D Branan Medical Corporation | DOE |
| Nov 22, 2000 | K002417 | BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D Branan Medical Corporation | DJR |
| Nov 22, 2000 | K002337 | BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST Branan Medical Corporation | DIS |
| Nov 22, 2000 | K002272 | BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D Branan Medical Corp. | LCM |
| Nov 22, 2000 | K002266 | BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST Branan Medical Corporation | DKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2016 | Branan Medical Corporation 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 Ana Terminated |
DIO | K082898 |
| Apr 24, 2014 | Branan Medical Corporation 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. Terminated |
DIO | K032057 |