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
7585–7608 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 27, 1989
ATYPICAL CHOLINESTERASE
K873496 · DIH
Sclavo, Inc.
Chemistry · 528d
Cleared Jan 27, 1989
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
K880049 · DIH
Sclavo, Inc.
Chemistry · 387d
Cleared Jan 27, 1989
CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE
K880199 · DIH
Sclavo, Inc.
Chemistry · 380d
Cleared Jan 27, 1989
BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD
K883967 · JGJ
Beckman Instruments, Inc.
Chemistry · 129d
Cleared Jan 27, 1989
TECHNICON RA-100 SYSTEM CALCIUM METHOD
K884599 · CIC
Technicon Instruments Corp.
Chemistry · 85d
Cleared Jan 27, 1989
TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE
K884601 · CHJ
Technicon Instruments Corp.
Chemistry · 85d
Cleared Jan 27, 1989
ANALYST THYROXINE (T4) ROTOR
K884700 · KLI
The DU Pont Co.
Chemistry · 79d
Cleared Jan 27, 1989
LIPOCLEAR LIPEMIA CLEARING REAGENT
K884807 · JKA
Statspin Technologies
Chemistry · 71d
Cleared Jan 27, 1989
GAS TRAK PLUS
K884977 · JJY
United Diagnostics, Inc.
Chemistry · 58d
Cleared Jan 27, 1989
TARGET READER
K885254 · JQT
V-Tech, Inc.
Chemistry · 35d
Cleared Jan 24, 1989
DU PONT ANALYST THYROID ROTOR
K884169 · CEL
The DU Pont Co.
Chemistry · 112d
Cleared Jan 23, 1989
CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
K883327 · JGZ
Heraeus Kulzer, Inc.
Chemistry · 168d
Cleared Jan 23, 1989
ALBUWELL
K884146 · JIR
Exocell, Inc.
Chemistry · 112d
Cleared Jan 23, 1989
TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM
K884600 · JGJ
Technicon Instruments Corp.
Chemistry · 81d
Cleared Jan 23, 1989
TOTAL PROTEIN TEST (TP) ITEM #65670
K884703 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Jan 23, 1989
URIC ACID TEST (URIC) ITEM #65620
K884704 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Jan 17, 1989
FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884707 · LCS
Cyberfluor, Inc.
Chemistry · 69d
Cleared Jan 17, 1989
FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884708 · CGJ
Cyberfluor, Inc.
Chemistry · 69d
Cleared Jan 17, 1989
MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
K884769 · CEM
Ciba Corning Diagnostics Corp.
Chemistry · 64d
Cleared Jan 17, 1989
MAGNESIUM TEST ITEM NUMBER: SR1019
K885022 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
ELECTR-TRANSBLOTTER
K882344 · JJN
The W.E.P. Co.
Chemistry · 220d
Cleared Jan 13, 1989
FIRSTDAY EARLY PREGNANCY TESTING KIT II
K884616 · JHI
Pacific Biotech, Inc.
Chemistry · 70d
Cleared Jan 13, 1989
CLINISTAT GLUCOSE REAGENT TEST
K884756 · CGA
Heraeus Kulzer, Inc.
Chemistry · 60d
Cleared Jan 13, 1989
PREGNAGEN(TM)
K884880 · JHI
Biogenex Laboratories
Chemistry · 53d