Tcpi, Inc.
Medical device manufacturer in Ft. Lauderdale, FL.
14510(k) clearances
0PMA approvals
0recalls
Device types
- JHI Visual, Pregnancy Hcg, Prescription Use 2
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter 2
- CEP Radioimmunoassay, Luteinizing Hormone 1
- DIO Enzyme Immunoassay, Cocaine And Cocaine… 1
- DJG Enzyme Immunoassay, Opiates 1
- JMT Diazo (Colorimetric), Nitrite (Urinary… 1
- JIL Method, Enzymatic, Glucose (Urinary… 1
- LDJ Enzyme Immunoassay, Cannabinoids 1
- JXM Enzyme Immunoassay, Benzodiazepine 1
- DKZ Enzyme Immunoassay, Amphetamine 1
- JIR Indicator Method, Protein Or Albumin… 1
- LCM Enzyme Immunoassay, Phencyclidine 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K981363 | One Step Urine Drug of Abuse: Phencyclidine (PCP) TestLCM · Traditional | 12/22/1998SE |
| K972960 | Health Check Uri-Test Protein in UrineJIR · Traditional | 10/07/1998SE |
| K981197 | One Step Urine Drug of Abuse Amphetamine TestDKZ · Traditional | 06/16/1998SE |
| K980776 | One Step Urine Drug of Abuse: Benzodiazepine TestJXM · Traditional | 04/29/1998SE |
| K951853 | One Step Urine Drug of Abuse Cannabinoid Test (THC)LDJ · Traditional | 08/20/1996SE |
| K954968 | Health Check Uri-Test Glucose in Urine TestJIL · Traditional | 07/26/1996SE |
| K954685 | Uritest - Nitrite in Urine TestJMT · Traditional | 07/22/1996SE |
| K955353 | One Step Pregnancy HCG Serun Diluent ReagentJHI · Traditional | 03/19/1996SE |
| K952096 | One Step Urine Drug of Abuse Opiate Test (Opium/Heroin/Morphine)DJG · Traditional | 08/17/1995SE |
| K951892 | One Step Urine Drug of Abuse Cocaine TestDIO · Traditional | 08/17/1995SE |
| K941765 | HCG Pregnancy One Step Test Strip for OTC UseLCX · Traditional | 10/20/1994SE |
| K935134 | One Step LH TestCEP · Traditional | 01/11/1994SE |
| K934830 | HCG Pregnancy One Step Test StripLCX · Traditional | 12/02/1993SE |
| K923123 | HCG Pregnancy One Step Test StripJHI · Traditional | 09/09/1992SE |