Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Corning Medical & Scientific · Predicate Candidate Screening

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

37 daysmedian FDA review time
95 days90th percentile
111clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K875122DISPOSABLE STERILE SYRINGE FILTERSCorning Medical & Scientific1988-01-12280
K872273CORNING EASY WASH ELISA PLATESCorning Medical & Scientific1987-07-07220
K872076CORNING DISPOSABLE ROLLER BOTTLESCorning Medical & Scientific1987-06-15170
K863789CORNING ELISA PLATESCorning Medical & Scientific1986-10-0370
K854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYCorning Medical & Scientific1985-11-26570
K853634CORNING CELL WELLS-MULTIPLE WELL PLATESCorning Medical & Scientific1985-09-16170
K851939CORNING CERTAIN -ISECorning Medical & Scientific1985-06-14420
K851329MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOACorning Medical & Scientific1985-06-13700
K850806CORNING BLOOD COLLECTION CAPILLARY TUBESCorning Medical & Scientific1985-03-25260
K850617CORNING 780 FLUOROMETER/DENSITOMETERCorning Medical & Scientific1985-03-12250
K844671CORNING DISPOSAL STERILE FILTER SYSTEM-NYLONCorning Medical & Scientific1985-02-25870
K850140CORNING MAGIC 1-FREE T3 RADIOIMMUNOASSAYCorning Medical & Scientific1985-02-06230
K844188CORNING CALCIUM PH ANALYZER 634Corning Medical & Scientific1985-02-041010
K843530CORNING 614 NA/K ANALYZERCorning Medical & Scientific1984-12-11950
K843614CORNING IMMUNOFIXATION SYSCorning Medical & Scientific1984-10-05210
K843397CORNING HIGH RESOLUTION PROTEIN ELECTROCorning Medical & Scientific1984-09-14160
K841641CORNING MAGIC CORTISOL RADIOIMMUNOCorning Medical & Scientific1984-09-041370
K840462VITAMIN B12 57CO/FOLATE 125I -Corning Medical & Scientific1984-06-251440
K841433CORNING LACTATE DEHYDROPHORETIC ASSAYCorning Medical & Scientific1984-05-16400
K840222CORNING IMMO PHASE FREE T3Corning Medical & Scientific1984-05-071090
K840460CORNINGS MAGIC FERRITIN RADIOIMMUNO-Corning Medical & Scientific1984-03-30570
K840187IMMOPHASE DTESTO RADIOIMMUNOASSAY-Corning Medical & Scientific1984-03-23650
K840461MAGIC 125I DIGOXIN RADIOIMMUNOASSAYCorning Medical & Scientific1984-03-23500
K834508CORNING 4000 MULTI-WELL GAMMA COUNTERCorning Medical & Scientific1984-03-16860
K840556DISPOSABLE SYRINGE FILTERSCorning Medical & Scientific1984-03-05260
K833406IMMOPHASE D-TE 3 RADIOIMMUNOASSAYCorning Medical & Scientific1984-01-241160
K832313MAGIC TSH 125I RADIOIMMUNOASSAYCorning Medical & Scientific1983-09-01490
K832381CORNING MAGIC SINGLE STEP FREE T4Corning Medical & Scientific1983-09-01440
K832353CORNING'S MAGIC T3(125I) RADIOIMMUNO-Corning Medical & Scientific1983-08-31440
K831613MAGIC TM 125I T3 UPTAKE RADIOASSAYCorning Medical & Scientific1983-08-11840
K832028CERTAIN HB CO-OXIMETER CONTROLCorning Medical & Scientific1983-07-18250
K831263ELECTROPHORESIS CONTROLS-3 IN 1Corning Medical & Scientific1983-07-07800
K831533MAGIC T4 125I RADIOIMMUNOASSAYCorning Medical & Scientific1983-06-30480
K831450DISPOSABLE STERILE FILTER SYSTEMCorning Medical & Scientific1983-06-02280
K830804LABILE REMOVING HEMOLYZING REAGENTCorning Medical & Scientific1983-05-04510
K830880IMMO PHASE DIRECT PROGESTERONE RADIO-Corning Medical & Scientific1983-04-18310
K830590CORNING 2500 CO-OXIMETERCorning Medical & Scientific1983-04-05400
K830296CORNING 102 PRINTERCorning Medical & Scientific1983-03-25570
K830591CORNING FERRITIN 125I RADIOIMMUNOASSAYCorning Medical & Scientific1983-03-24280
K830118ALKALINE PHOSPHATES ISOENZYME SUBSTRATECorning Medical & Scientific1983-02-25450
K830036NEONATAL NTSH RADIOIMMUNOASSAY SYSCorning Medical & Scientific1983-01-28210
K823688DOUBLE ANTIBODY TSH I-125 RADIOIMMUNOCorning Medical & Scientific1983-01-05290
K82374724 CELL WELLS TISSUE CULTURECorning Medical & Scientific1983-01-05230
K823292IMMOPHASE TM HPL RADIOIMMUNOASSAYCorning Medical & Scientific1982-12-28530
K823570CORNING 170 PH/BLOOD GAS ANALYZERCorning Medical & Scientific1982-12-28250
K823144SINGLE STEP FREE-T4 125I RADIOIMMUNO-Corning Medical & Scientific1982-11-29350
K822288LH (125I) RADIOIMMUNOASSAYCorning Medical & Scientific1982-09-13450
K822227IMMO PHASE FSH RADIOIMMUNOASSAYCorning Medical & Scientific1982-08-16200
K822146CORNING 101 PRINTERCorning Medical & Scientific1982-08-05150
K821398CORNING CPF 550 LENSCorning Medical & Scientific1982-06-25450

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