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
5113–5136 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 07, 1995
LACTATE DEHYDROGENASE REAGENT SYSTEM
K952747 · CFJ
Medical Diagnostic Technologies, Inc.
Chemistry · 52d
Cleared Aug 04, 1995
AI-PHOTODIAGNOSTIC
K940004 · CIB
Pharmarceutical Discovery Corp.
Chemistry · 578d
Cleared Aug 04, 1995
IL TEST CK-MB
K952646 · CGS
Instrumentation Laboratory CO
Chemistry · 56d
Cleared Aug 02, 1995
MAGNETIC HDL CHOLESTEROL TEST
K944975 · LBR
Reference Diagnostics, Inc.
Chemistry · 295d
Cleared Aug 02, 1995
5STRATEC SL 300 LIA-MAT
K950029 · JJQ
Nichols Institute Diagnostics
Chemistry · 210d
Cleared Aug 02, 1995
HICHEM AST REAGENT KIT
K951751 · CIT
Hichem Diagnostics
Chemistry · 107d
Cleared Aug 01, 1995
BIO-RAD URINARY 5-HIAA BY HPLC
K952817 · CDA
Bio-Rad
Chemistry · 42d
Cleared Jul 31, 1995
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, &...
K952555 · MOJ
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Jul 26, 1995
ROBOCAP
K952025 · JQW
Pharmacia, Inc.
Chemistry · 86d
Cleared Jul 26, 1995
AMERLITE TBG ASSAY
K952284 · CEE
Johnson & Johnson Clinical...
Chemistry · 71d
Cleared Jul 20, 1995
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
K952127 · CHH
Boehringer Mannheim Corp.
Chemistry · 73d
Cleared Jul 20, 1995
IL TEST LIPASE
K952647 · CHI
Instrumentation Laboratory CO
Chemistry · 41d
Cleared Jul 20, 1995
LIPASE FLEX REAGENT CARTRIDGE
K952816 · CHI
Dupont Medical Products
Chemistry · 30d
Cleared Jul 19, 1995
SELECTA 20/60 CHEMISTRY ANALYZER
K942922 · JJE
Select Medical Systems, Inc.
Chemistry · 393d
Cleared Jul 19, 1995
INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)
K944788 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 294d
Cleared Jul 19, 1995
HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF...
K950354 · LCX
Ml Strategies, Inc.
Chemistry · 170d
Cleared Jul 19, 1995
KENLOR LIQUID TOTAL URINE CONTROL
K952840 · JJW
Kenlor Industries, Inc.
Chemistry · 28d
Cleared Jul 17, 1995
ACTIVE INTACT PTH ELISA
K952199 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 68d
Cleared Jul 17, 1995
STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB...
K952250 · JHS
Dade Intl., Inc.
Chemistry · 63d
Cleared Jul 17, 1995
ACTIVE FREE TESTOSTERONE RIA
K952281 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 62d
Cleared Jul 17, 1995
AMERLITE HCG-60 ASSAY
K952283 · DHA
Johnson & Johnson Clinical...
Chemistry · 62d
Cleared Jul 14, 1995
GLUCOMETER ELITE M BLOOD GLUCOSE METER
K951537 · CGA
Bayer Corp.
Chemistry · 102d
Cleared Jul 14, 1995
AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q)
K952211 · JLW
Johnson & Johnson Clinical...
Chemistry · 64d
Cleared Jul 14, 1995
PRO-VENT, LINE DRAW, PULSATOR
K952516 · JKA
Smiths Industries Medical Systems, Inc.
Chemistry · 44d