American Diagnostic Corp.

Hauppauge, NY, US

AMERICAN DIAGNOSTIC CORP. appears in FDA device records in Hauppauge, NY. FDA records list 39 510(k) clearances between 1980-10-31 and 2017-03-10, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 39
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 39 510(k) clearances for American Diagnostic Corp. between 1980 and 2017. The busiest year on record is 1982, with 12. The most recent is 2017, with 1.

Clearances by year, as a table

510(k) clearance decisions for American Diagnostic Corp., by decision year
Year	Clearances
1980	5
1981	4
1982	12
1983	2
1986	3
1987	1
1989	4
1993	1
1994	2
1997	1
2001	1
2006	1
2010	1
2017	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K162589	Adscope 658 Electronic Stethoscope	DQD	Substantially Equivalent	2017-03-10
K093495	OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS	HLJ	Substantially Equivalent	2010-11-19
K060321	ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK	DQD	Substantially Equivalent	2006-05-15
K012304	ADC 656 ELECTRONIC STETHOSCOPE	DQD	Substantially Equivalent	2001-11-01
K962655	ANEROID AND MERCURIAL SPHYGMOMANOMETERS	DXQ	Substantially Equivalent	1997-01-27
K940686	ELECTRONIC THERMOMETERS	FLL	Substantially Equivalent	1994-07-08
K935944	PROSCOPES AND ADSCOPES	LDE	Substantially Equivalent	1994-03-03
K932145	COAGULATION REFERENCE PLASMA, NORMAL	GIZ	Substantially Equivalent	1993-10-18
K894169	BIOTEL MICROALBUMINURIA (TM)	JIR	Substantially Equivalent	1989-09-18
K893608	ACTICHROME ATIII KIT	JBQ	Substantially Equivalent	1989-06-23
K884941	ACTICLOT C KIT	GGP	Substantially Equivalent	1989-03-13
K884940	RELLPLATE C KIT, RELLPLATE C BULK PLATES	GGP	Substantially Equivalent	1989-03-13
K870500	MAJOR QUALITY GLUCOSE AND KETONES URINE TEST	JIL	Substantially Equivalent	1987-03-06
K855239	BIOTEL (TM)/ DIABETES	JIL	Substantially Equivalent	1986-06-13
K855238	BIOTEL (TM)/UTI	JMT	Substantially Equivalent	1986-05-09
K855237	BIOTEL (TM)/ KIDNEY	KHE	Substantially Equivalent	1986-05-06
K832493	QUINIDINE FLUORESCENT IMMUNOASSAY	LBZ	Substantially Equivalent	1983-09-12
K831377	IGE RADIOIMMUNOASSAY KIT	DGC	Substantially Equivalent	1983-06-02
K823062	KENAMYCIN FLUORESCENT IMMUNOASSAY FIA	KJI	Substantially Equivalent	1982-11-10
K822941	NETILMICIN FLUORESCENT IMMUNOASSAY	LCE	Substantially Equivalent	1982-10-26
K822347	LIDOCAINE FLUORESCENT IMMUNOASSAY	KLR	Substantially Equivalent	1982-08-25
K822308	VANCOMYCIN FLUORESCENT IMMUNOASSAY	LEH	Substantially Equivalent	1982-08-16
K822229	PRIMIDONE FLUORESCENT IMMUNOASSAY	LFT	Substantially Equivalent	1982-08-12
K821945	CARBAMAZEPINE FLOURESCENT IMMUNOASSAY	KLT	Substantially Equivalent	1982-07-16
K821807	AMERIFLOUR FLUOROMETER	JQP	Substantially Equivalent	1982-07-02
K821408	PHENOBARBITAL FLUORESCENT IMMUNO	LET	Substantially Equivalent	1982-05-24
K820397	AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM	LER	Substantially Equivalent	1982-03-02
K820274	DIGOXIN RADIOIMMUNOASSAY	DPB	Substantially Equivalent	1982-02-23
K813542	TOBRAMYCIN FLUORESCENT IMMUNOASSAY	LCR	Substantially Equivalent	1982-01-12
K813541	AMIKACIN FLUORESCENT IMMUNOASSAY	KLQ	Substantially Equivalent	1982-01-12
K813540	A FLUOROMETER	KHO	Substantially Equivalent	1981-12-31
K813539	GENTAMICIN FLUORESCENT IMMUNOASSAY	LCQ	Substantially Equivalent	1981-12-31
K813538	PHENYTOIN FLUORESCENT IMMUNOASSAY	LES	Substantially Equivalent	1981-12-31
K803098	TRI-LEVEL RADIOASSAY CONTROL SERA	JJY	Substantially Equivalent	1981-01-09
K802841	DIGOXIN RADIOIMMUNOASSAY KIT	DNL	Substantially Equivalent	1980-12-18
K802470	T3 RADIOIMMUNOASSAY KIT	CDP	Substantially Equivalent	1980-11-12
K802469	T4 RADIOIMMUNOASSAY KIT	CDX	Substantially Equivalent	1980-11-12
K802468	T3 UPTAKE TEST SYSTEM	KHQ	Substantially Equivalent	1980-10-31
K802467	TSH RADIOIMMUNOASSAY KIT	JLW	Substantially Equivalent	1980-10-31

Registered establishments

FDA registered establishments for American Diagnostic Corp., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2434008	2434008	AMERICAN DIAGNOSTIC CORP.	55 COMMERCE DR., HAUPPAUGE, NY 11788 US	2026	BYG BZS CAE CCW DPW DQA DQD DXN DXQ EPY and 21 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets American Diagnostic Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain