Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

66 results for "Diagnostic Reagents, Inc."
1–24 of 66
Search insights Median review: 58d Cleared: 100% Top manufacturer: Diagnostic Reagents, Inc. Lead specialty: Toxicology
Cleared Nov 18, 1998
MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
K983268 · LFH
Diagnostic Reagents, Inc.
Toxicology · 62d
Cleared Nov 16, 1998
NAPA EIA ASSAY
K983812 · LAN
Diagnostic Reagents, Inc.
Toxicology · 19d
Cleared Nov 12, 1998
DIGOXIN IMMUNOASSAY
K983323 · KXT
Diagnostic Reagents, Inc.
Toxicology · 51d
Cleared Nov 06, 1998
VANCOMYCIN EIA ASSAY
K983280 · LEH
Diagnostic Reagents, Inc.
Toxicology · 49d
Cleared Nov 05, 1998
DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
K983159 · DKB
Diagnostic Reagents, Inc.
Toxicology · 57d
Cleared Sep 12, 1997
LIDOCAINE EIA ASSAY
K973102 · KLR
Diagnostic Reagents, Inc.
Toxicology · 24d
Cleared Aug 28, 1997
50NG/ML COCAINE METABOLITE CALIBRATOR
K972835 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 28d
Cleared Aug 04, 1997
METHADONE EIA ASSAY
K972526 · DJR
Diagnostic Reagents, Inc.
Toxicology · 39d
Cleared Dec 18, 1996
QUINIDINE ENZYME IMMUNOASSAY
K964212 · LBZ
Diagnostic Reagents, Inc.
Toxicology · 57d
Cleared Dec 10, 1996
DIGOXIN ENZYME IMMUNOASSAY
K963835 · KXT
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Aug 14, 1996
PROCAINAMIDE ENZYME IMMUNOASSAY
K962463 · LAR
Diagnostic Reagents, Inc.
Toxicology · 50d
Cleared Jul 16, 1996
VALPROIC ACID EIA TEST
K961988 · LEG
Diagnostic Reagents, Inc.
Toxicology · 56d
Cleared Jul 08, 1996
ACETAMINOPHEN SERUM TOX EIA ASSAY
K961373 · LDP
Diagnostic Reagents, Inc.
Toxicology · 90d
Cleared Jun 12, 1996
TRICYCLICS SERUM TOX ASSAY
K961393 · LFH
Diagnostic Reagents, Inc.
Toxicology · 62d
Cleared May 20, 1996
BENZODIAZEPINE SERUM TOX EIA TEST
K960708 · JXM
Diagnostic Reagents, Inc.
Toxicology · 89d
Cleared May 15, 1996
AED CALIBRATORS
K961273 · DKB
Diagnostic Reagents, Inc.
Toxicology · 43d
Cleared May 06, 1996
BARBITURATE SERUM TOX EIA ASSAY
K960664 · DIS
Diagnostic Reagents, Inc.
Toxicology · 80d
Cleared May 01, 1996
SERUM TOX CALIBRATOR
K961372 · DKB
Diagnostic Reagents, Inc.
Toxicology · 22d
Cleared Apr 29, 1996
SALICYLATE ASSAY
K961131 · DKJ
Diagnostic Reagents, Inc.
Toxicology · 39d
Cleared Apr 02, 1996
COCAINE METABOLITE EIA TEST
K960187 · DIO
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Mar 18, 1996
PRIMIDONE EIA TEST
K960526 · DJP
Diagnostic Reagents, Inc.
Toxicology · 41d
Cleared Mar 11, 1996
BARBITURATE EIA ESSAY (MODIFICATION)
K955928 · DIS
Diagnostic Reagents, Inc.
Toxicology · 84d
Cleared Dec 13, 1995
CARBAMAZEPINE EIA TEST
K955100 · KLT
Diagnostic Reagents, Inc.
Toxicology · 35d
Cleared Oct 20, 1995
PH-DETECT TEST
K952178 · JQY
Diagnostic Reagents, Inc.
Chemistry · 164d