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

107 results for "Microgenics Corp."
73–96 of 107
Search insights Median review: 67d Cleared: 99% Top manufacturer: Microgenics Corp. Lead specialty: Toxicology
Cleared Mar 14, 1994
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB
K936028 · DKB
Microgenics Corp.
Toxicology · 87d
Cleared Mar 14, 1994
CEDIA DAU NEGATIVE CALIBRATOR
K935793 · DKB
Microgenics Corp.
Toxicology · 97d
Cleared Mar 11, 1994
CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS
K935904 · DIO
Microgenics Corp.
Toxicology · 91d
Cleared Mar 03, 1994
CEDIA T4 MAB ASSAY MODIFICATION
K935880 · KLI
Microgenics Corp.
Chemistry · 87d
Cleared Jan 25, 1994
CEDIA DAU 4-DRUG CUTOFF CALIBRATOR
K935794 · DKB
Microgenics Corp.
Toxicology · 49d
Cleared Jan 25, 1994
CEDIA DAU 5-DRUG CALIBRATORS
K935792 · DKB
Microgenics Corp.
Toxicology · 49d
Cleared Jan 13, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K935591 · LDJ
Microgenics Corp.
Toxicology · 55d
Cleared Jan 11, 1994
CEDIA(R) DAU OPIATE ASSAY
K935346 · DJG
Microgenics Corp.
Toxicology · 67d
Cleared Dec 29, 1993
CEDIA DIGOXIN PLUS ASSAY
K934168 · KXT
Microgenics Corp.
Toxicology · 124d
Cleared Sep 21, 1993
CEDIA VALPORIC ACID ASSAY
K930734 · LEG
Microgenics Corp.
Toxicology · 222d
Cleared Sep 15, 1992
CEDIA DIGOXIN PLUS ASSAY
K923853 · KXT
Microgenics Corp.
Toxicology · 50d
Cleared Jun 16, 1992
CEDIA RED BLOOD CELL FOLATE REAGENT PACK
K921689 · CGN
Microgenics Corp.
Chemistry · 69d
Cleared Jun 04, 1992
CEDIA FERRITIN ASSAY
K920318 · JMG
Microgenics Corp.
Chemistry · 132d
Cleared Mar 02, 1992
CEDIA DIGOXIN ASSAY (MODIFICATION)
K920214 · KXT
Microgenics Corp.
Toxicology · 46d
Cleared Jan 15, 1992
CEDIA(R) CARBAMAZEPINE ASSAY
K914857 · KLT
Microgenics Corp.
Toxicology · 78d
Cleared Sep 27, 1991
CEDIA(R) GENTAMICIN ASSAY
K913470 · LCD
Microgenics Corp.
Toxicology · 53d
Cleared Jul 26, 1991
CEDIA(R) TOBRAMYCIN ASSAY
K912143 · LFW
Microgenics Corp.
Toxicology · 72d
Cleared May 15, 1991
CEDIA(R) DIGOXIN R' ASSAY
K911941 · KXT
Microgenics Corp.
Toxicology · 14d
Cleared Mar 21, 1991
CEDIA(R) DIGOXIN SC ASSAY
K910642 · KXT
Microgenics Corp.
Toxicology · 36d
Cleared Jan 17, 1991
CEDIA PHENYTOIN ASSAY
K905689 · DIP
Microgenics Corp.
Toxicology · 29d
Cleared Dec 26, 1990
CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
K905521 · LER
Microgenics Corp.
Toxicology · 19d
Cleared Nov 20, 1990
CEDIA (R) VITAMIN B12/FOLATE ASSAY
K904776 · CDD
Microgenics Corp.
Chemistry · 29d
Cleared Nov 05, 1990
CEDIA(TM) PHENOBARBITAL ASSAY
K904413 · LAF
Microgenics Corp.
Toxicology · 40d
Cleared Sep 27, 1990
CEDIA TOTAL T3 ASSAY
K904098 · CDP
Microgenics Corp.
Chemistry · 21d