FDA 510(k) Applications for Medical Device Product Code "MSQ"
|
FDA 510(k) Number | Applicant | Device Name | Decision Date |
K973000 | ALIMENTERICS, INC. | ALIMENTERICS LARA (TM) BREATH TEST SYSTEM | 02/26/1998 |
K173777 | Exalenz Bioscience Ltd. | BreathID Hp Lab System | 03/08/2018 |
K162150 | Exalenz Bioscience Ltd. | BreathID Hp Lab System | 10/31/2016 |
K130524 | EXALENZ BIOSCIENCE LTD. | BREATHID HP SYSTEM | 05/22/2013 |
K173772 | Exalenz Bioscience Ltd. | BreathID Hp System | 03/08/2018 |
K193610 | Exalenz Bioscience Ltd. | BreathID Smart System | 02/06/2020 |
K093834 | HEMA METRICS, LLC | CRIT-LINE ANEMIA MANAGEMENT SOFTWARE | 09/29/2010 |
K000316 | MERETEK | MERETEK UBT_LITE BREATH TEST FOR H. PYLORI | 02/24/2000 |
K014225 | MERETEK DIAGNOSTICS, INC. | BREATHTEK - UBIT UBT FOR H. PYLORI | 01/17/2002 |
K972352 | MERETEK DIAGNOSTICS, INC. | THE MERETEK UBT BREATH TEST FOR H.PYLORI | 10/29/1997 |
K220494 | Meridian Bioscience Israel Ltd. | BreathID Hp Lab System, BreathID Smart System | 06/23/2022 |
K221896 | Meridian Bioscience Israel Ltd. | BreathID Hp System | 12/19/2022 |
K223185 | Meridian Bioscience Israel Ltd. | BreathID« Smart System | 11/10/2022 |
K990931 | METABOLIC SOLUTIONS, INC. | EZ-HBT HELICOBACTER BLOOD TEST | 09/24/1999 |
K011668 | ORIDION MEDICAL 1987 LTD. | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI | 07/09/2001 |
K092817 | OTSUKA PHARMACEUTICAL CO., LTD. | POC-AS10 AUTO SAMPLER | 03/09/2010 |
K041148 | OTSUKA PHARMACEUTICAL CO., LTD. | POCONE INFRARED SPECTROPHOTOMETER | 07/15/2004 |