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
9097–9120 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 11, 1986
MAGNESIUM REAGENT SET
K860215 · JGJ
Sterling Diagnostics, Inc.
Chemistry · 20d
Cleared Feb 11, 1986
AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA
K860251 · CEC
Amersham Corp.
Chemistry · 18d
Cleared Feb 11, 1986
AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA
K860252 · CDP
Amersham Corp.
Chemistry · 18d
Cleared Feb 11, 1986
TOTAL PROTEIN (BIURET) REAGENT SET
K860341 · CEK
Sterling Diagnostics, Inc.
Chemistry · 13d
Cleared Feb 11, 1986
ALKALINE PHOSPHATASE REAGENT SET
K860351 · CIO
Sterling Diagnostics, Inc.
Chemistry · 12d
Cleared Feb 11, 1986
CREATININE REAGENT SET
K860418 · CGX
Sterling Diagnostics, Inc.
Chemistry · 7d
Cleared Feb 11, 1986
UREA NITROGEN REAGENT SET
K860419 · CDW
Sterling Diagnostics, Inc.
Chemistry · 7d
Cleared Feb 11, 1986
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
K860421 · CDX
American Dade
Chemistry · 7d
Cleared Feb 10, 1986
TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500
K854406 · JQW
Tecan U.S., Ltd.
Chemistry · 101d
Cleared Feb 10, 1986
URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE
K860143 · JJP
Reagent Laboratory, Inc.
Chemistry · 26d
Cleared Feb 06, 1986
EIA PROCESSOR
K854936 · JJE
Abbott Laboratories
Chemistry · 58d
Cleared Feb 06, 1986
V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT
K854971 · KLI
V-Tech, Inc.
Chemistry · 57d
Cleared Feb 06, 1986
T3 UPTAKE RADIOIMMUNOASSAY KIT
K855169 · KHQ
Cambridge Medical Technology
Chemistry · 42d
Cleared Feb 06, 1986
LDH (OPTIMIZED) REAGENT
K860029 · CFJ
Sigma Chemical Co.
Chemistry · 31d
Cleared Feb 06, 1986
ENZYMATIC UREA NITROGEN REAGENT SET
K860109 · CDQ
Technostics Intl.
Chemistry · 24d
Cleared Feb 06, 1986
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
K860134 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Feb 06, 1986
BUN (ENZYMATIC BERTHELOT) REAGENT SET
K860154 · CDL
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Jan 28, 1986
DSL ANDROSTENEDIONE RIA (DSL #4200)
K854675 · JLS
Diagnostic Systems Laboratories, Inc.
Chemistry · 68d
Cleared Jan 28, 1986
ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM
K854805 · CFT
Nichols Institute Diagnostics
Chemistry · 57d
Cleared Jan 28, 1986
HCG RIA TEST SYSTEM
K854958 · JHI
Monobind
Chemistry · 48d
Cleared Jan 28, 1986
TOTAL CHOLESTEROL REAGENT SET
K855028 · CHH
Sterling Diagnostics, Inc.
Chemistry · 43d
Cleared Jan 24, 1986
T-3 UPTAKE/RIASSAY
K855033 · KHQ
Ria Diagnostics
Chemistry · 38d
Cleared Jan 24, 1986
OLYMPUS AU 5000 CHEMISTRY ANALYZER SYSTEM
K860080 · JJE
Olympus Corp.
Chemistry · 16d
Cleared Jan 24, 1986
TOTAL LIPIDS REAGENT SET
K860112 · CFD
Technostics Intl.
Chemistry · 11d