Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

American Diagnostic Corp. · Predicate Candidate Screening

39 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

34 daysmedian FDA review time

167 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days
K162589	Adscope 658 Electronic Stethoscope	American Diagnostic Corp.	2017-03-10	175
K093495	OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS	American Diagnostic Corp.	2010-11-19	374
K060321	ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK	American Diagnostic Corp.	2006-05-15	95
K012304	ADC 656 ELECTRONIC STETHOSCOPE	American Diagnostic Corp.	2001-11-01	104
K962655	ANEROID AND MERCURIAL SPHYGMOMANOMETERS	American Diagnostic Corp.	1997-01-27	203
K940686	ELECTRONIC THERMOMETERS	American Diagnostic Corp.	1994-07-08	142
K935944	PROSCOPES AND ADSCOPES	American Diagnostic Corp.	1994-03-03	80
K932145	COAGULATION REFERENCE PLASMA, NORMAL	American Diagnostic Corp.	1993-10-18	167
K894169	BIOTEL MICROALBUMINURIA (TM)	American Diagnostic Corp.	1989-09-18	95
K893608	ACTICHROME ATIII KIT	American Diagnostic Corp.	1989-06-23	44
K884941	ACTICLOT C KIT	American Diagnostic Corp.	1989-03-13	105
K884940	RELLPLATE C KIT, RELLPLATE C BULK PLATES	American Diagnostic Corp.	1989-03-13	105
K870500	MAJOR QUALITY GLUCOSE AND KETONES URINE TEST	American Diagnostic Corp.	1987-03-06	30
K855239	BIOTEL (TM)/ DIABETES	American Diagnostic Corp.	1986-06-13	164
K855238	BIOTEL (TM)/UTI	American Diagnostic Corp.	1986-05-09	129
K855237	BIOTEL (TM)/ KIDNEY	American Diagnostic Corp.	1986-05-06	126
K832493	QUINIDINE FLUORESCENT IMMUNOASSAY	American Diagnostic Corp.	1983-09-12	47
K831377	IGE RADIOIMMUNOASSAY KIT	American Diagnostic Corp.	1983-06-02	36
K823062	KENAMYCIN FLUORESCENT IMMUNOASSAY FIA	American Diagnostic Corp.	1982-11-10	23
K822941	NETILMICIN FLUORESCENT IMMUNOASSAY	American Diagnostic Corp.	1982-10-26	22
K822347	LIDOCAINE FLUORESCENT IMMUNOASSAY	American Diagnostic Corp.	1982-08-25	19
K822308	VANCOMYCIN FLUORESCENT IMMUNOASSAY	American Diagnostic Corp.	1982-08-16	13
K822229	PRIMIDONE FLUORESCENT IMMUNOASSAY	American Diagnostic Corp.	1982-08-12	16
K821945	CARBAMAZEPINE FLOURESCENT IMMUNOASSAY	American Diagnostic Corp.	1982-07-16	17
K821807	AMERIFLOUR FLUOROMETER	American Diagnostic Corp.	1982-07-02	15
K821408	PHENOBARBITAL FLUORESCENT IMMUNO	American Diagnostic Corp.	1982-05-24	13
K820397	AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM	American Diagnostic Corp.	1982-03-02	19
K820274	DIGOXIN RADIOIMMUNOASSAY	American Diagnostic Corp.	1982-02-23	21
K813542	TOBRAMYCIN FLUORESCENT IMMUNOASSAY	American Diagnostic Corp.	1982-01-12	22
K813541	AMIKACIN FLUORESCENT IMMUNOASSAY	American Diagnostic Corp.	1982-01-12	22
K813540	A FLUOROMETER	American Diagnostic Corp.	1981-12-31	10
K813538	PHENYTOIN FLUORESCENT IMMUNOASSAY	American Diagnostic Corp.	1981-12-31	10
K813539	GENTAMICIN FLUORESCENT IMMUNOASSAY	American Diagnostic Corp.	1981-12-31	10
K803098	TRI-LEVEL RADIOASSAY CONTROL SERA	American Diagnostic Corp.	1981-01-09	32
K802841	DIGOXIN RADIOIMMUNOASSAY KIT	American Diagnostic Corp.	1980-12-18	36
K802469	T4 RADIOIMMUNOASSAY KIT	American Diagnostic Corp.	1980-11-12	34
K802470	T3 RADIOIMMUNOASSAY KIT	American Diagnostic Corp.	1980-11-12	34
K802467	TSH RADIOIMMUNOASSAY KIT	American Diagnostic Corp.	1980-10-31	22
K802468	T3 UPTAKE TEST SYSTEM	American Diagnostic Corp.	1980-10-31	22

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda