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
9121–9144 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 22, 1986
SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV
K854245 · KQN
Sigma Diagnostics, Inc.
Chemistry · 93d
Cleared Jan 22, 1986
DSL ANDROSTENEDIONE RIA (DSL # 4200)
K854673 · CIZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 62d
Cleared Jan 22, 1986
TRIGLYCERIDE'S TEST (TRIGLI-CINET)
K854783 · CDT
Sclavo, Inc.
Chemistry · 54d
Cleared Jan 22, 1986
V-TREND DIG ENZYME IMMUNOASSAY TEST KIT
K854972 · KXT
V-Tech, Inc.
Chemistry · 42d
Cleared Jan 22, 1986
SERALYZER TOTAL BILIRUBIN CALIBRATORS
K855040 · JIS
Miles Laboratories, Inc.
Chemistry · 36d
Cleared Jan 22, 1986
CALCIUM LIQUID STABLE REAGENT SET
K855041 · CIC
Medical Analysis Systems, Inc.
Chemistry · 36d
Cleared Jan 22, 1986
EMDS TOTAL CK TEST PACK-#67670/95
K855056 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jan 22, 1986
GLUCOSE REAGENT SET
K855185 · CGE
Technostics Intl.
Chemistry · 27d
Cleared Jan 22, 1986
CLEANING REAGENT KIT PRODUCT NO 88194
K855196 · JJE
Hi Chem, Inc.
Chemistry · 27d
Cleared Jan 21, 1986
LACTIC DEHYDROGENASE (VV) REAGENT SET
K855157 · CFJ
Technostics Intl.
Chemistry · 26d
Cleared Jan 17, 1986
KODAK EKTACHEM HDL CHOLESTEROL KIT
K854426 · CHH
Eastman Kodak Company
Chemistry · 73d
Cleared Jan 17, 1986
CREATININE PAP
K854766 · JFY
Boehringer Mannheim Corp.
Chemistry · 51d
Cleared Jan 17, 1986
CANTROL ELECTROPHORESIS CONTROL
K854931 · JJY
Canyon Diagnostics, Inc.
Chemistry · 38d
Cleared Jan 17, 1986
TDXR 5-HIAA (URINE)
K854946 · CDA
Abbott Laboratories
Chemistry · 38d
Cleared Jan 17, 1986
CANTROL CK/MB CONTROL
K855006 · JJT
Canyon Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 17, 1986
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
K855225 · JJX
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Jan 15, 1986
T-4 RIASSAY
K854798 · CDX
Ria Diagnostics
Chemistry · 44d
Cleared Jan 14, 1986
NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928
K854717 · CEK
Nobel Scientific Industries, Inc.
Chemistry · 53d
Cleared Jan 14, 1986
VISION SGOT (AST)
K854982 · CIT
Abbott Laboratories
Chemistry · 33d
Cleared Jan 14, 1986
GLUCOSE (UV HEXOKIASE) REAGENT SET
K855153 · CFR
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
INORGANIC PHOSPHORUS REAGENT SET
K855154 · CEO
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET
K855156 · JPZ
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
ALBUMIN REAGENT SET
K855158 · CIX
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
LACTIC DEHYDROGENASE REAGENT SET
K855159 · CFJ
Technostics Intl.
Chemistry · 19d