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
7801–7824 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 28, 1988
QTEST(TM) PREGNANCY
K882086 · JHI
Quidel Corp.
Chemistry · 71d
Cleared Jul 28, 1988
CLEARBLUE EASY
K882416 · LCX
Unipath , Ltd.
Chemistry · 45d
Cleared Jul 28, 1988
GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.
K882450 · JJE
Diamond Sensor Systems
Chemistry · 44d
Cleared Jul 21, 1988
AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST
K881142 · CGJ
Amersham Corp.
Chemistry · 126d
Cleared Jul 21, 1988
REAGENTS FOR TSH ASSAY
K881381 · JLW
Sclavo, Inc.
Chemistry · 111d
Cleared Jul 21, 1988
DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023
K882259 · JIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 51d
Cleared Jul 21, 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
K882542 · JJY
Bio-Rad
Chemistry · 30d
Cleared Jul 12, 1988
TRACER(TM) II BLOOD GLUCOSE SYSTEM
K881908 · CGA
Boehringer Mannheim Corp.
Chemistry · 67d
Cleared Jul 08, 1988
QUANTAI BG(TM) REAGENT STRIP
K880703 · CGA
Quantai Biotronics, Inc.
Chemistry · 137d
Cleared Jul 08, 1988
BLOOD PH CAPILLARY TUBES, HEPARIN
K881188 · CHL
Helps Products, Inc.
Chemistry · 109d
Cleared Jul 08, 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503 · JJY
Baxter Healthcare Corp
Chemistry · 88d
Cleared Jul 08, 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
K881639 · CEK
Eastman Kodak Company
Chemistry · 85d
Cleared Jul 08, 1988
CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
K881679 · DON
Ciba Corning Diagnostics Corp.
Chemistry · 80d
Cleared Jul 08, 1988
IMMUNOCARD(TM) HCG II TEST KIT
K881709 · JHI
Disease Detection International, Inc.
Chemistry · 79d
Cleared Jul 08, 1988
BIOTROL ALKALINE PHOSPHATASE
K881742 · CJE
Biotrol, USA, Inc.
Chemistry · 77d
Cleared Jul 08, 1988
UNSATURATED IRON BINDING CAPACITY
K881761 · JMO
Data Medical Associates, Inc.
Chemistry · 74d
Cleared Jul 08, 1988
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170
K881852 · JJN
Helena Laboratories
Chemistry · 67d
Cleared Jul 06, 1988
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS
K881437 · JJY
Hichem Diagnostics
Chemistry · 92d
Cleared Jul 06, 1988
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
K881438 · JJY
Hichem Diagnostics
Chemistry · 92d
Cleared Jul 06, 1988
TDX (R) DIGOXIN NXT
K882233 · KXT
Abbott Laboratories
Chemistry · 40d
Cleared Jul 05, 1988
ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT.
K882104 · JGS
Paramax Systems Div. Baxter Healthcare
Chemistry · 47d
Cleared Jul 01, 1988
DSL SOMATOMEDIN-C (DSL #5600)
K875229 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 192d
Cleared Jul 01, 1988
NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
K880750 · JGS
Nova Biomedical Corp.
Chemistry · 128d
Cleared Jul 01, 1988
CLP LIPOPROTEIN ELECTROPHORESIS CONTROL
K881113 · JJY
Creative Laboratory Products, Inc.
Chemistry · 108d