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

Filters: Toxicology ×
3,029 results
2113–2136 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Aug 11, 1987
ION TRAP DETECTOR (ITD)
K872464 · DOP
The Perkin-Elmer Corp.
Toxicology · 49d
Cleared Jul 21, 1987
ETHANOL CALIBRATOR
K872181 · DLJ
American Monitor Corp.
Toxicology · 43d
Cleared Jul 21, 1987
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
K872397 · LGQ
Roche Diagnostic Systems, Inc.
Toxicology · 29d
Cleared Jul 21, 1987
INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET
K872461 · DLJ
Innotron of Oregon, Inc.
Toxicology · 27d
Cleared Jul 21, 1987
INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET
K872462 · DLJ
Innotron of Oregon, Inc.
Toxicology · 29d
Cleared Jul 21, 1987
INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET
K872463 · DLJ
Innotron of Oregon, Inc.
Toxicology · 27d
Cleared Jul 21, 1987
INNOFLUOR VANCOMYCIN CALIBRATOR SET
K872644 · DLJ
Innotron of Oregon, Inc.
Toxicology · 15d
Cleared Jul 09, 1987
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95
K872330 · DKJ
Em Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jul 07, 1987
HYPERFORMANCE CONTROLS (HP-CONTROLS)
K871694 · DIF
Rapid Diagnostic Laboratories, Inc.
Toxicology · 70d
Cleared Jul 07, 1987
KINETIC 610 ETHANOL
K872180 · DML
American Monitor Corp.
Toxicology · 29d
Cleared Jul 07, 1987
DIGOXIN FPIA CONTROLS
K872347 · LAS
Sigma Diagnostics, Inc.
Toxicology · 20d
Cleared Jun 17, 1987
ACCULEVEL CARBAMAZEPINE TEST
K871254 · KLT
Syva Co.
Toxicology · 79d
Cleared Jun 17, 1987
THEOPHYLLINE FPIA CONTROLS
K871589 · LAW
Sigma Chemical Co.
Toxicology · 54d
Cleared Jun 17, 1987
8000 SERIES GAS CHROMATOGRAPHS
K872122 · KZQ
The Perkin-Elmer Corp.
Toxicology · 15d
Cleared Jun 11, 1987
4-9295 BARBITURATES TEST MIX
K871174 · DKB
Supelco, Inc.
Toxicology · 79d
Cleared Jun 11, 1987
PHENYTOIN FPIA CALIBRATORS
K871423 · DLJ
Sigma Diagnostics, Inc.
Toxicology · 63d
Cleared Jun 08, 1987
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
K871680 · LAN
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Jun 05, 1987
COCAINE METABOLITE ENZYME IMMUNOASSAY KIT
K871305 · DIO
General Diagnostics
Toxicology · 65d
Cleared Jun 05, 1987
DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5
K871695 · LDJ
Diagnostic Products Corp.
Toxicology · 36d
Cleared Jun 05, 1987
DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD5
K871696 · DKZ
Diagnostic Products Corp.
Toxicology · 36d
Cleared Jun 01, 1987
KDI QUIK TEST(TM) MARIJUANA SCREEN
K870197 · LDJ
Keystone Diagnostics, Inc.
Toxicology · 132d
Cleared Jun 01, 1987
THEOPHYLLINE FPIA CALIBRATORS
K871394 · DLJ
Sigma Diagnostics, Inc.
Toxicology · 55d
Cleared May 12, 1987
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
K871329 · LCD
Em Diagnostic Systems, Inc.
Toxicology · 39d
Cleared May 06, 1987
CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3
K864456 · LAS
Cala Diagnostics
Toxicology · 174d