Data / Medical devices / United States / American Diagnostic Corp.
American Diagnostic Corp.: FDA-registered device maker in Hauppauge, NY, United States, 50 510(k) clearances
American Diagnostic Corp. is registered with the FDA (registration 2434008) in Hauppauge, NY, United States. It lists 31 device types. The FDA files 50 510(k) clearances under its listings, the newest dated December 20, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2434008
- Address
- 55 Commerce DR., Hauppauge, NY, United States, 11788
- Owner or operator
- AMERICAN DIAGNOSTIC (2434008)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- June 29, 1994
- Registered through
- 2027
- Brand names listed
- 3600BK, 3691, 3693, 3693BK, 3693DG, 3693RB, 3693ST, 3695 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 20, 2023 | K233130 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| June 28, 2023 | K230075 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| March 8, 2023 | K220101 | Pulse Oximeter | DQA | Substantially Equivalent | Beijing Choice Electronic Technology Co., Ltd. | accessdata.fda.gov |
| March 22, 2021 | K202009 | Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026 | FLL | Substantially Equivalent | Shenzhen Juzhong Technology Co., Ltd. | accessdata.fda.gov |
| February 25, 2021 | K203332 | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C | FLL | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| July 16, 2019 | K183663 | Microlife Digital Infrared Ear Thermometer | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| July 23, 2018 | K171888 | Non-contact infrared body thermometer | FLL | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| August 30, 2017 | K170467 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| March 10, 2017 | K162589 | Adscope 658 Electronic Stethoscope | DQD | Substantially Equivalent | American Diagnostic Corp. | accessdata.fda.gov |
| October 5, 2016 | K161560 | Fingertip Pulse Oximeter MD300CN310 | DQA | Substantially Equivalent | Beijing Choice Electronic Technology Co., Ltd. | accessdata.fda.gov |
| July 6, 2016 | K160439 | SunTech CT40 Spot-check Vital Signs Device | DXN | Substantially Equivalent | Suntech Medical | accessdata.fda.gov |
| October 21, 2015 | K152770 | ProBP 2400 Digital Blood Pressure Device | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| May 15, 2015 | K143728 | Minhua Disposable Blood Pressure Cuff | DXQ | Substantially Equivalent | Suzhou Minhua Medical Apparatus | accessdata.fda.gov |
| August 22, 2014 | K141083 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| October 3, 2013 | K130947 | FINGERTIP PULSE OXIMETER | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
| August 30, 2013 | K131818 | VITAL SIGNS MONITOR | DQA | Substantially Equivalent | Edan Instruments, Inc. | accessdata.fda.gov |
| February 25, 2011 | K102947 | NON-CONTACT INFRARED THERMOMETER | FLL | Substantially Equivalent | K-Jump Health Co., Ltd. | accessdata.fda.gov |
| January 10, 2011 | K102508 | YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 | FLL | Substantially Equivalent | Yu Long Sheng Technology Co., Ltd. | accessdata.fda.gov |
| December 2, 2010 | K101577 | MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
| November 19, 2010 | K093495 | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS | HLJ | Substantially Equivalent | American Diagnostic Corp. | accessdata.fda.gov |
| June 2, 2010 | K100563 | GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA | FLL | Substantially Equivalent | Geon Corporation | accessdata.fda.gov |
| May 17, 2010 | K100953 | MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| April 3, 2009 | K082846 | APK SPO2 PULSE OXIMETER SENSOR | DQA | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
| June 24, 2008 | K081160 | AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| December 20, 2007 | K073398 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) | DXN | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| December 20, 2007 | K073397 | MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) | DXN | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| May 2, 2007 | K070750 | 247 BP DEVICE | DXN | Substantially Equivalent | Suntech Medical, Inc. | accessdata.fda.gov |
| February 8, 2007 | K070028 | CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER | FLL | Substantially Equivalent | Actherm, Inc. | accessdata.fda.gov |
| September 11, 2006 | K061471 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| August 10, 2006 | K061086 | DM-3000 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Nihon Seimitsu Sokki Co., Ltd. | accessdata.fda.gov |
| June 9, 2006 | K060686 | MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| May 15, 2006 | K060321 | ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK | DQD | Substantially Equivalent | American Diagnostic Corp. | accessdata.fda.gov |
| February 3, 2006 | K053006 | ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II | DXQ | Substantially Equivalent | Rossmax Internationl , Ltd. | accessdata.fda.gov |
| September 9, 2005 | K051904 | ALL PURPOSE CUFF, MODEL 222APC | DXQ | Substantially Equivalent | Suntech Medical, Inc. | accessdata.fda.gov |
| December 9, 2004 | K043110 | MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| July 21, 2004 | K041411 | MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP | DXN | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| January 15, 2004 | K034023 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| December 4, 2003 | K032362 | UP-GRADE FOREHEAD THERMOMETER | FLL | Substantially Equivalent | Medisim, Ltd. | accessdata.fda.gov |
| September 12, 2003 | K030961 | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 | LHD | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| August 22, 2000 | K000969 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 | FLL | Substantially Equivalent | Microlife Corp. | accessdata.fda.gov |
| September 24, 1999 | K992686 | DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR | LZA | Substantially Equivalent | Sheen More Ent. Co., Ltd. | accessdata.fda.gov |
| February 12, 1999 | K983887 | UP-GRADE AND UP-GRADE PRO | FLL | Substantially Equivalent | Medisim, Ltd. | accessdata.fda.gov |
| April 30, 1998 | K970211 | MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR | DPW | Substantially Equivalent | Micro Weiss Electronics | accessdata.fda.gov |
| January 27, 1997 | K962655 | ANEROID AND MERCURIAL SPHYGMOMANOMETERS | DXQ | Substantially Equivalent | American Diagnostic Corp. | accessdata.fda.gov |
| July 24, 1995 | K950914 | RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V | HLJ | Substantially Equivalent | Rudolf Riester GmbH & Co. KG | accessdata.fda.gov |
| May 12, 1995 | K950913 | PERFECT, ENT SET, PRAKTIKANT, DE LUXE | ERA | Substantially Equivalent | Rudolf Riester GmbH & Co. KG | accessdata.fda.gov |
| July 8, 1994 | K940686 | ELECTRONIC THERMOMETERS | FLL | Substantially Equivalent | American Diagnostic Corp. | accessdata.fda.gov |
| October 8, 1993 | K932506 | RI-SCOPE (S) | ERA | Substantially Equivalent | Rudolf Riester GmbH & Co. KG | accessdata.fda.gov |
| October 22, 1990 | K903590 | KEJUMP DIGITAL CLINICAL THERMOMETER | FLL | Substantially Equivalent | K-Jump Health Co., Ltd. | accessdata.fda.gov |
| May 23, 1985 | K851146 | DIGITAL THERMOMETER | FLL | Substantially Equivalent | Micro Idea Instrument Co., Ltd. | accessdata.fda.gov |
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Updated December 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.