AMERICAN DIAGNOSTIC CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2434008	2434008	AMERICAN DIAGNOSTIC CORP.	1	Y	2026-01-01	55 COMMERCE DR. HAUPPAUGE NY US 11788

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
37629	1581286048	K992686	DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR	LZA	1999-09-24
37629	1557256602	K983887	UP-GRADE AND UP-GRADE PRO	FLL	1999-02-12
37629	1937642779	K983406	SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR	FLL	1998-10-19
37629	1379329259	K974195	FLEXIBLE TIP DIGITAL THERMOMETER	FLL	1998-02-04
37629	1303359932	K970211	MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR	DPW	1998-04-30
37629	1872316781	K970139	MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO	DPW	1998-04-30
37629	1717162853	K962655	ANEROID AND MERCURIAL SPHYGMOMANOMETERS	DXQ	1997-01-27
37629	1955450826	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	1995-07-24
37629	2062489530	K950913	PERFECT, ENT SET, PRAKTIKANT, DE LUXE	ERA	1995-05-12
37629	1693832484	K940686	ELECTRONIC THERMOMETERS	FLL	1994-07-08
37629	1694698993	K932506	RI-SCOPE (S)	ERA	1993-10-08
37629	1456606251	K932503	RI-MINI	ERA	1993-10-08
37629	1189924819	K903590	KEJUMP DIGITAL CLINICAL THERMOMETER	FLL	1990-10-22
37629	1618069949	K851146	DIGITAL THERMOMETER	FLL	1985-05-23
37629	1470608190	K233130	Blood Pressure Monitor	DXN	2023-12-20
37629	1257160884	K230075	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K	DXN	2023-06-28
37629	1121764909	K220101	Pulse Oximeter	DQA	2023-03-08
37629	1570867195	K203332	Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C	FLL	2021-02-25
37629	1422791552	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	2021-03-22
37629	1552421959	K183663	Microlife Digital Infrared Ear Thermometer	FLL	2019-07-16
37629	1064162975	K171888	Non-contact infrared body thermometer	FLL	2018-07-23
37629	1650339309	K170467	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	DXN	2017-08-30
37629	1334600253	K162589	Adscope 658 Electronic Stethoscope	DQD	2017-03-10
37629	1186443460	K161560	Fingertip Pulse Oximeter MD300CN310	DQA	2016-10-05
37629	1603949714	K160439	SunTech CT40 Spot-check Vital Signs Device	DXN	2016-07-06
37629	1653738755	K152770	ProBP 2400 Digital Blood Pressure Device	DXN	2015-10-21
37629	1156762488	K143728	Minhua Disposable Blood Pressure Cuff	DXQ	2015-05-15
37629	1302045303	K141083	MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR	DXN	2014-08-22
37629	1268367182	K131818	VITAL SIGNS MONITOR	DQA	2013-08-30
37629	1907727574	K130947	FINGERTIP PULSE OXIMETER	DQA	2013-10-03
37629	1287043831	K102947	NON-CONTACT INFRARED THERMOMETER	FLL	2011-02-25
37629	1097492617	K102508	YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02	FLL	2011-01-10
37629	1499530193	K101577	MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES	DQA	2010-12-02
37629	1367990222	K100953	MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1	FLL	2010-05-17
37629	1694396105	K100563	GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA	FLL	2010-06-02
37629	1437066165	K093495	OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS	HLJ	2010-11-19
37629	1326104542	K091040	MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1	FLL	2009-05-13
37629	1058074282	K082846	APK SPO2 PULSE OXIMETER SENSOR	DQA	2009-04-03
37629	1089145493	K081160	AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES	FLL	2008-06-24
37629	1505093901	K073398	MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100)	DXN	2007-12-20
37629	1661201202	K073397	MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50)	DXN	2007-12-20
37629	1662351668	K070750	247 BP DEVICE	DXN	2007-05-02
37629	1562367700	K070371	FINGERTIP PULSE OXIMETER MD300C	DQA	2007-08-13
37629	2053631966	K070028	CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER	FLL	2007-02-08
37629	1289941900	K061558	MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U	DXN	2006-06-29
37629	1448452990	K061471	MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC	DXN	2006-09-11
37629	1752164984	K061086	DM-3000 DIGITAL BLOOD PRESSURE MONITOR	DXN	2006-08-10
37629	1904812077	K061007	GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS	FLL	2006-06-14
37629	1405773590	K060686	MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC	DXN	2006-06-09
37629	1176765144	K060321	ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK	DQD	2006-05-15
37629	1312163853	K053006	ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II	DXQ	2006-02-03
37629	1823792271	K051904	ALL PURPOSE CUFF, MODEL 222APC	DXQ	2005-09-09
37629	2005752636	K043110	MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1	FLL	2004-12-09
37629	1426234814	K041411	MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP	DXN	2004-07-21
37629	1922096299	K034023	MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1	FLL	2004-01-15
37629	2054814871	K032362	UP-GRADE FOREHEAD THERMOMETER	FLL	2003-12-04
37629	1054857965	K030961	MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921	LHD	2003-09-12
37629	2020207688	K001182	MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1	DXN	2000-08-01
37629	1846283015	K000969	MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1	FLL	2000-08-22
37629	1131451278
37629	1158146800
37629	1271972730
37629	1316629626
37629	1423585780
37629	1482802649
37629	1495407932
37629	1539391732
37629	1551349028
37629	1555666003
37629	1584616611
37629	1586966434
37629	1650820741
37629	1666495709
37629	1707978976
37629	1814168456
37629	1877231535
37629	1897480373
37629	1911656969
37629	1940219823
37629	1952119238
37629	2042966675

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FLL	22	2021-03-22
DXN	15	2023-12-20
DQA	7	2023-03-08
DXQ	4	2015-05-15
ERA	3	1995-05-12
DQD	2	2017-03-10
HLJ	2	2010-11-19
DPW	2	1998-04-30
LHD	1	2003-09-12
LZA	1	1999-09-24

PMN#

Adscope 658 Electronic Stethoscope
2017-03-10
AMERICAN DIAGNOSTIC CORP.
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
2010-11-19
AMERICAN DIAGNOSTIC CORP.
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
2006-05-15
AMERICAN DIAGNOSTIC CORP.
ADC 656 ELECTRONIC STETHOSCOPE
2001-11-01
AMERICAN DIAGNOSTIC CORP.
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
1997-01-27
AMERICAN DIAGNOSTIC CORP.
ELECTRONIC THERMOMETERS
1994-07-08
AMERICAN DIAGNOSTIC CORP.
PROSCOPES AND ADSCOPES
1994-03-03
AMERICAN DIAGNOSTIC CORP.
COAGULATION REFERENCE PLASMA, NORMAL
1993-10-18
AMERICAN DIAGNOSTIC CORP.
BIOTEL MICROALBUMINURIA (TM)
1989-09-18
AMERICAN DIAGNOSTIC CORP.
ACTICHROME ATIII KIT
1989-06-23
AMERICAN DIAGNOSTIC CORP.
RELLPLATE C KIT, RELLPLATE C BULK PLATES
1989-03-13
AMERICAN DIAGNOSTIC CORP.
ACTICLOT C KIT
1989-03-13
AMERICAN DIAGNOSTIC CORP.
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
1987-03-06
AMERICAN DIAGNOSTIC CORP.
BIOTEL (TM)/ DIABETES
1986-06-13
AMERICAN DIAGNOSTIC CORP.
BIOTEL (TM)/UTI
1986-05-09
AMERICAN DIAGNOSTIC CORP.
BIOTEL (TM)/ KIDNEY
1986-05-06
AMERICAN DIAGNOSTIC CORP.
QUINIDINE FLUORESCENT IMMUNOASSAY
1983-09-12
AMERICAN DIAGNOSTIC CORP.
IGE RADIOIMMUNOASSAY KIT
1983-06-02
AMERICAN DIAGNOSTIC CORP.
KENAMYCIN FLUORESCENT IMMUNOASSAY FIA
1982-11-10
AMERICAN DIAGNOSTIC CORP.
NETILMICIN FLUORESCENT IMMUNOASSAY
1982-10-26
AMERICAN DIAGNOSTIC CORP.
LIDOCAINE FLUORESCENT IMMUNOASSAY
1982-08-25
AMERICAN DIAGNOSTIC CORP.
VANCOMYCIN FLUORESCENT IMMUNOASSAY
1982-08-16
AMERICAN DIAGNOSTIC CORP.
PRIMIDONE FLUORESCENT IMMUNOASSAY
1982-08-12
AMERICAN DIAGNOSTIC CORP.
CARBAMAZEPINE FLOURESCENT IMMUNOASSAY
1982-07-16
AMERICAN DIAGNOSTIC CORP.
AMERIFLOUR FLUOROMETER
1982-07-02
AMERICAN DIAGNOSTIC CORP.
PHENOBARBITAL FLUORESCENT IMMUNO
1982-05-24
AMERICAN DIAGNOSTIC CORP.
AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM
1982-03-02
AMERICAN DIAGNOSTIC CORP.
DIGOXIN RADIOIMMUNOASSAY
1982-02-23
AMERICAN DIAGNOSTIC CORP.
TOBRAMYCIN FLUORESCENT IMMUNOASSAY
1982-01-12
AMERICAN DIAGNOSTIC CORP.
AMIKACIN FLUORESCENT IMMUNOASSAY
1982-01-12
AMERICAN DIAGNOSTIC CORP.
PHENYTOIN FLUORESCENT IMMUNOASSAY
1981-12-31
AMERICAN DIAGNOSTIC CORP.
GENTAMICIN FLUORESCENT IMMUNOASSAY
1981-12-31
AMERICAN DIAGNOSTIC CORP.
A FLUOROMETER
1981-12-31
AMERICAN DIAGNOSTIC CORP.
TRI-LEVEL RADIOASSAY CONTROL SERA
1981-01-09
AMERICAN DIAGNOSTIC CORP.
DIGOXIN RADIOIMMUNOASSAY KIT
1980-12-18
AMERICAN DIAGNOSTIC CORP.
T4 RADIOIMMUNOASSAY KIT
1980-11-12
AMERICAN DIAGNOSTIC CORP.
T3 RADIOIMMUNOASSAY KIT
1980-11-12
AMERICAN DIAGNOSTIC CORP.
TSH RADIOIMMUNOASSAY KIT
1980-10-31
AMERICAN DIAGNOSTIC CORP.
T3 UPTAKE TEST SYSTEM
1980-10-31
AMERICAN DIAGNOSTIC CORP.