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
9265–9288 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 30, 1985
BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER
K853453 · JJQ
Bio Automed Systems, Inc.
Chemistry · 45d
Cleared Sep 30, 1985
URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS
K853825 · KNK
Catachem, Inc.
Chemistry · 17d
Cleared Sep 30, 1985
GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS
K853826 · CFR
Catachem, Inc.
Chemistry · 17d
Cleared Sep 30, 1985
ALBUMIN SR LIQUID STABLE REAGENT SET
K853868 · CIX
Medical Analysis Systems, Inc.
Chemistry · 13d
Cleared Sep 30, 1985
LIQUI-SERA CHEM. MULTIPLE CALIBRATORS
K853887 · JIT
Biodiagnostic Intl
Chemistry · 11d
Cleared Sep 25, 1985
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
K853539 · JHI
Abbott Laboratories
Chemistry · 33d
Cleared Sep 25, 1985
EASY ANALYZER & EASY-TEST REAGENT
K853699 · JJE
Diagnostic Systems
Chemistry · 21d
Cleared Sep 25, 1985
APOLLO DENSITOMETER
K853734 · JQT
Astral Medical Systems
Chemistry · 19d
Cleared Sep 18, 1985
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS
K853548 · LCM
American Dade
Chemistry · 23d
Cleared Sep 18, 1985
SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY
K853628 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 20d
Cleared Sep 16, 1985
REFLOTRON SYSTEM
K852133 · JJE
Boehringer Mannheim Corp.
Chemistry · 123d
Cleared Sep 16, 1985
MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
K853127 · CDD
Micromedic Systems
Chemistry · 53d
Cleared Sep 16, 1985
ALCOHOL CALIBRATORS
K853532 · DNN
Diagnostic Systems
Chemistry · 24d
Cleared Sep 16, 1985
ABSORBANCE TEST SOLUTION
K853533 · JIT
Diagnostic Systems
Chemistry · 24d
Cleared Sep 16, 1985
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I
K853547 · LAN
American Dade
Chemistry · 21d
Cleared Sep 16, 1985
DIASCAN CONTROL
K853553 · JJX
Home Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 16, 1985
MAGNESIUM
K853592 · JGJ
Pointe Scientific, Inc.,
Chemistry · 20d
Cleared Sep 16, 1985
QCA ENZYMATIC GLUCOSE
K853656 · CGA
Bd Becton Dickinson Vacutainer...
Chemistry · 13d
Cleared Sep 16, 1985
TDX REA BUN
K853677 · CDQ
Abbott Laboratories
Chemistry · 12d
Cleared Sep 04, 1985
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY
K852845 · JFH
Diagnostic Products Corp.
Chemistry · 61d
Cleared Sep 04, 1985
HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY
K853006 · JHI
Modern Diagnostics, Inc.
Chemistry · 50d
Cleared Sep 04, 1985
GLUCOSE SR LIQUID STABLE REAGENT SET
K853464 · CFR
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Sep 04, 1985
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
K853531 · CEM
American Dade
Chemistry · 12d
Cleared Sep 03, 1985
TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE
K852611 · CDM
Miles Laboratories, Inc.
Chemistry · 76d