FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
10465–10488 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 06, 1983
GLUCOSE REAGENT KITS-B6370-10A
K831624 · CGA
American Scientific Products
Chemistry · 47d
Cleared Jul 06, 1983
CREATININE REAGENTS B6360-10
K831627 · CGX
American Scientific Products
Chemistry · 47d
Cleared Jul 06, 1983
CREATININE REAGENTS B6370-13
K831628 · CGX
American Scientific Products
Chemistry · 47d
Cleared Jun 30, 1983
QUINIDINE REAGENT TEST KIT
K830963 · LBZ
Beckman Instruments, Inc.
Chemistry · 94d
Cleared Jun 30, 1983
SPECIFIC GRAVITY INSTRUMENT
K831213 · JRE
Iris
Chemistry · 77d
Cleared Jun 30, 1983
AMYLASE REAGENT #88129
K831295 · KHM
Hi Chem, Inc.
Chemistry · 71d
Cleared Jun 30, 1983
ISO-SEP SYSTEM
K831434 · CDP
Berwick Medical Products, Inc.
Chemistry · 57d
Cleared Jun 30, 1983
MAGIC T4 125I RADIOIMMUNOASSAY
K831533 · CDX
Corning Medical & Scientific
Chemistry · 48d
Cleared Jun 30, 1983
E.P.T. PLUS TM
K831535 · JHJ
Warner-Lambert Co.
Chemistry · 48d
Cleared Jun 30, 1983
REAGENT CUPS
K831569 · JJG
American Scientific Products
Chemistry · 45d
Cleared Jun 30, 1983
ROTOR
K831571 · JJG
American Scientific Products
Chemistry · 45d
Cleared Jun 22, 1983
BLOOD GAS & FLAME PHOTOMETER INSTRU-
K831075 · CGC
United Diagnostics, Inc.
Chemistry · 79d
Cleared Jun 22, 1983
EVENT-TEST SLIDE
K831383 · JHJ
Icl Scientific
Chemistry · 55d
Cleared Jun 22, 1983
PTH MR
K831470 · CEW
Ramco Laboratories, Inc.
Chemistry · 47d
Cleared Jun 22, 1983
LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN
K831478 · LCP
Bio-Rad
Chemistry · 44d
Cleared Jun 22, 1983
PARAMAX ALKALINE PHOSPHATASE REAGENT-
K831480 · CJE
American Dade
Chemistry · 44d
Cleared Jun 22, 1983
URI-TEST 3, INLAB REAGENT STRIPS-URINAL
K831498 · JIL
Laprol Scientific, Inc.
Chemistry · 42d
Cleared Jun 22, 1983
AUTO CAROUSE/WASH SOLUTION CONCENTRATE
K831518 · JJE
Syva Co.
Chemistry · 41d
Cleared Jun 22, 1983
RPMI-1640 MEDIUM W/L-GLUTAMINE &
K831519 · KIT
Sigma Chemical Co.
Chemistry · 41d
Cleared Jun 22, 1983
PARAMAX CREATINE KINASE REAGENT
K831537 · CGS
American Dade
Chemistry · 44d
Cleared Jun 17, 1983
DEMAND ANALYZER SYSTEM
K831477 · JJE
Worthington Diagnostic Systems
Chemistry · 39d
Cleared Jun 17, 1983
GLUCOSE 3, INLAB REAGENT STRIPS-URINALY
K831499 · JIN
Laprol Scientific, Inc.
Chemistry · 37d
Cleared Jun 17, 1983
PARAMAX AMALINE REAGENT
K831536 · JFJ
American Dade
Chemistry · 39d
Cleared Jun 16, 1983
CALIBRATING SOLUTION FOR ABL-1 & 2
K831018 · CHL
Fisher Scientific Co., LLC
Chemistry · 78d