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
8425–8448 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 08, 1987
IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR
K871664 · JIX
Instrumentation Laboratory CO
Chemistry · 10d
Cleared May 06, 1987
CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II
K871537 · JJY
Canyon Diagnostics, Inc.
Chemistry · 16d
Cleared Apr 29, 1987
CALCIUM TEST
K870629 · CIC
Sclavo, Inc.
Chemistry · 75d
Cleared Apr 29, 1987
TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091
K870958 · CEF
Helena Laboratories
Chemistry · 50d
Cleared Apr 29, 1987
ULTRA-VIOLET GLUCOSE REAGENT KIT
K871456 · CFR
Biochemical Trade, Inc.
Chemistry · 16d
Cleared Apr 23, 1987
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
K871414 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared Apr 22, 1987
BIOMEK 1000 AUTOMATED LABORATORY WORK STATION
K870544 · JQW
Beckman Instruments, Inc.
Chemistry · 72d
Cleared Apr 22, 1987
T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT
K870573 · CDX
Cambridge Medical Technology
Chemistry · 71d
Cleared Apr 22, 1987
CHLORIDE TEST
K870630 · CHJ
Sclavo, Inc.
Chemistry · 68d
Cleared Apr 22, 1987
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
K870928 · CHH
Electro-Nucleonics Laboratories, Inc.
Chemistry · 44d
Cleared Apr 22, 1987
WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM
K870949 · LDM
Millipore Corp.
Chemistry · 43d
Cleared Apr 22, 1987
ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD
K871301 · CDT
American Monitor Corp.
Chemistry · 21d
Cleared Apr 22, 1987
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM
K871319 · JHO
Helena Laboratories
Chemistry · 19d
Cleared Apr 22, 1987
FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814
K871320 · CDW
American Research Products Co.
Chemistry · 19d
Cleared Apr 22, 1987
FLOW-PAC INORGANIC PHOSPHORUS REAGENTS
K871321 · CEO
American Research Products Co.
Chemistry · 19d
Cleared Apr 22, 1987
MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)
K871415 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 14d
Cleared Apr 22, 1987
COLORIMETRIC URIC ACID REAGENT SET
K871417 · KNK
Biochemical Trade, Inc.
Chemistry · 15d
Cleared Apr 14, 1987
SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
K870752 · CFJ
Miles Laboratories, Inc.
Chemistry · 48d
Cleared Apr 13, 1987
NEUROCHEMICAL ANALYZER
K864729 · LEQ
Esa, Inc.
Chemistry · 130d
Cleared Apr 13, 1987
AFFINITY DIGOXIN IMMUNIT
K870552 · KXT
Bd Becton Dickinson Vacutainer...
Chemistry · 62d
Cleared Apr 13, 1987
U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL
K870737 · JJT
U. S. Diagnostics, Inc.
Chemistry · 47d
Cleared Apr 13, 1987
U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL
K870738 · JJT
U. S. Diagnostics, Inc.
Chemistry · 47d
Cleared Apr 13, 1987
LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT
K870986 · JIY
Beckman Instruments, Inc.
Chemistry · 33d
Cleared Apr 13, 1987
PROGESTERONE CLASP RADIOIMMUNOASSAY KIT
K871211 · JLS
Biotecx Laboratories, Inc.
Chemistry · 18d