FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
4873–4896 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 14, 1996
AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE
K951877 · KQO
Chimera Research & Chemical, Inc.
Chemistry · 403d
Cleared May 13, 1996
ELECTROLYTE STANDARDS
K960592 · JJR
Phoenix Diagnostics, Inc.
Chemistry · 91d
Cleared May 10, 1996
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
K960485 · JMO
Beckman Instruments, Inc.
Chemistry · 98d
Cleared May 07, 1996
DSL ACTIVE I-HCG IRMA
K960357 · JHI
Diagnostic Systems Laboratories, Inc.
Chemistry · 103d
Cleared May 07, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
K961099 · JGS
Johnson & Johnson Clinical...
Chemistry · 49d
Cleared May 07, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)
K961115 · CEM
Johnson & Johnson Clinical...
Chemistry · 48d
Cleared May 07, 1996
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
K961226 · CJY
Johnson & Johnson Clinical...
Chemistry · 39d
Cleared May 06, 1996
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
K961043 · JKR
Scantibodies Laboratory, Inc.
Chemistry · 53d
Cleared May 02, 1996
KETOREX C SANWA
K953452 · JMK
Ihara Medics U.S., Inc.
Chemistry · 289d
Cleared May 02, 1996
ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
K955707 · DHA
Excel Scientific, Inc.
Chemistry · 139d
Cleared May 02, 1996
ENA-C-T TOTAL CHOLESTEROL TEST
K960377 · CHH
Actimed Laboratories, Inc.
Chemistry · 97d
Cleared May 02, 1996
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2
K961293 · JJY
Consolidated Technologies, Inc.
Chemistry · 28d
Cleared May 01, 1996
MINISTICK PREGNANCY TEST
K960733 · LCX
Vanguard Biomedical Corp.
Chemistry · 69d
Cleared Apr 30, 1996
STC DIAGNOSTICS AUTO-LYTE PH ASSAY
K954158 · KQO
Solarcare Technologies Corp,Inc.
Chemistry · 238d
Cleared Apr 30, 1996
TONOMETERED SLAINE BLOOD GAS CONTROL
K961441 · JJS
Instrumentarium Corp.
Chemistry · 15d
Cleared Apr 29, 1996
CLEARBLUE EASY
K960316 · LCX
Unipath , Ltd.
Chemistry · 97d
Cleared Apr 26, 1996
DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS
K960103 · JIX
Dade Intl., Inc.
Chemistry · 106d
Cleared Apr 26, 1996
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
K960561 · CFT
Diagnostic Systems Laboratories, Inc.
Chemistry · 77d
Cleared Apr 26, 1996
AVL OPTI 1 PH/BLOOD GAS ANALYZER
K961161 · CHL
Avl Scientific Corp.
Chemistry · 35d
Cleared Apr 25, 1996
OPUS CK-MB & TOTAL CK CONTROLS
K960275 · JJT
Behring Diagnostics, Inc.
Chemistry · 97d
Cleared Apr 25, 1996
BIONIKE A/Q PREGNANCY TEST
K960992 · JHI
Bionike Laboratories, Inc.
Chemistry · 44d
Cleared Apr 25, 1996
ALT INCORPORATING DST
K961123 · CKA
Trace Scientific , Ltd.
Chemistry · 35d
Cleared Apr 24, 1996
TOTAL PROTEIN (URINE)
K951222 · JIR
Randox Laboratories, Ltd.
Chemistry · 401d
Cleared Apr 24, 1996
AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3
K955690 · JJY
Clinical Controls, Inc.
Chemistry · 132d