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."
25–48 of 66
Search insights Median review: 58d Cleared: 100% Top manufacturer: Diagnostic Reagents, Inc. Lead specialty: Toxicology
Cleared Aug 11, 1995
THEOPHYLLINE ENZYME IMMUNOASSAY
K952596 · KLS
Diagnostic Reagents, Inc.
Toxicology · 66d
Cleared Jun 15, 1995
T-UPTAKE CALIBRATORS
K951585 · JIS
Diagnostic Reagents, Inc.
Chemistry · 70d
Cleared May 15, 1995
T-UPTAKE EIA TEST
K951586 · KHQ
Diagnostic Reagents, Inc.
Chemistry · 39d
Cleared Feb 10, 1995
PHENOBARBITAL ENZYME IMMUNOASSAY
K946210 · DLZ
Diagnostic Reagents, Inc.
Toxicology · 51d
Cleared Feb 03, 1995
PHENYTION EIA TEST
K945725 · DIP
Diagnostic Reagents, Inc.
Toxicology · 73d
Cleared Jan 17, 1995
THEOPHYLLINE CALIBRATORS
K945338 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Jan 04, 1995
PHENOBARBITAL CALIBRATORS
K945316 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 64d
Cleared Dec 09, 1994
THYROXINE ENZYME IMMUNOASSAY
K944703 · KLI
Diagnostic Reagents, Inc.
Chemistry · 77d
Cleared Dec 07, 1994
PHENYTOIN CALIBRATORS
K945337 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 36d
Cleared Nov 21, 1994
CALIBRATORS
K944701 · JIS
Diagnostic Reagents, Inc.
Chemistry · 59d
Cleared Nov 04, 1994
CANNABINOID EIA ASSAY
K943998 · LDJ
Diagnostic Reagents, Inc.
Toxicology · 136d
Cleared Sep 09, 1994
PROPOXPHENE EIA TEST
K943414 · JXN
Diagnostic Reagents, Inc.
Toxicology · 56d
Cleared Jul 06, 1994
URINE CALIBRATOR
K940935 · DKB
Diagnostic Reagents, Inc.
Toxicology · 131d
Cleared May 03, 1994
METHAQUALONE ENZYME IMMUNOASSAY
K940123 · KXS
Diagnostic Reagents, Inc.
Toxicology · 113d
Cleared Jan 27, 1994
URINE CALIBRATORS AND CONTROLS MODIFICATION
K935101 · DKB
Diagnostic Reagents, Inc.
Toxicology · 99d
Cleared Jan 26, 1994
METHADONE ENZYME IMMUNOASSAY
K934667 · DJR
Diagnostic Reagents, Inc.
Toxicology · 119d
Cleared Jan 13, 1994
AMPHETAMINES EIA ASSAY MODIFICATION
K934891 · DKZ
Diagnostic Reagents, Inc.
Toxicology · 114d
Cleared Dec 29, 1993
PHENCYCLIDINE EIA ASSAY
K935320 · LCM
Diagnostic Reagents, Inc.
Toxicology · 76d
Cleared Dec 03, 1993
COCAINE METABOLITE EIA ASSAY MODIFICATION
K935016 · DIO
Diagnostic Reagents, Inc.
Chemistry · 46d
Cleared Aug 23, 1993
METHADONE METABOLITE EIA ASSAY
K931780 · DJR
Diagnostic Reagents, Inc.
Toxicology · 136d
Cleared Aug 05, 1993
BENZODIAZEPINE ENZYME IMMUNOASSAY
K930529 · JXM
Diagnostic Reagents, Inc.
Toxicology · 184d
Cleared Jul 28, 1993
URINE CALIBRATOR AND CONTROL
K931506 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 125d
Cleared Jun 29, 1993
CANNABINOID URINE CONTROLS
K932113 · JJX
Diagnostic Reagents, Inc.
Toxicology · 57d
Cleared Jan 21, 1993
ETHYL ALCOHOL ASSAY
K923783 · DMT
Diagnostic Reagents, Inc.
Toxicology · 177d