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
4513–4536 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 21, 1997
TRIGLYCERIDES
K971005 · JGY
Derma Media Lab., Inc.
Chemistry · 33d
Cleared Apr 21, 1997
ALT OR SGPT
K971323 · CKA
Carolina Liquid Chemistries Corp.
Chemistry · 11d
Cleared Apr 21, 1997
AST OR SGOT
K971344 · CIT
Carolina Liquid Chemistries Corp.
Chemistry · 11d
Cleared Apr 21, 1997
SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT
K971363 · CEO
Carolina Liquid Chemistries Corp.
Chemistry · 14d
Cleared Apr 17, 1997
SASI-DC1TS
K970580 · KDW
Substance Abuse Specialties, Inc.
Chemistry · 62d
Cleared Apr 17, 1997
LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
K970778 · JJX
More Diagnostics
Chemistry · 44d
Cleared Apr 14, 1997
DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE
K970330 · CEM
Dade Intl., Inc.
Chemistry · 76d
Cleared Apr 14, 1997
AQUALITE INTACT PTH
K970483 · CEW
Sealite Sciences, Inc.
Chemistry · 63d
Cleared Apr 14, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL...
K970894 · DHA
Johnson & Johnson Clinical...
Chemistry · 34d
Cleared Apr 14, 1997
URIC, UA, OR URIC ACID
K971133 · KNK
Carolina Liquid Chemistries Corp.
Chemistry · 18d
Cleared Apr 08, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
K962208 · CGR
Nichols Institute Diagnostics
Chemistry · 302d
Cleared Apr 08, 1997
CLINISTRIP
K970250 · JIL
Teco Diagnostics
Chemistry · 76d
Cleared Apr 08, 1997
CARDIOISOZYME, CK/LD ISOENZYME CONTROL
K970856 · JJT
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Apr 08, 1997
SPINALSCOPICS
K970862 · JJY
Quantimetrix Corp.
Chemistry · 32d
Cleared Apr 08, 1997
STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C...
K970921 · JIX
Alko Diagnostic Corp.
Chemistry · 27d
Cleared Apr 08, 1997
ORGENTEC MICRO-ALBUMIN EIA ASSAY
K970932 · JIR
American Laboratory Products Co., Ltd.
Chemistry · 47d
Cleared Apr 08, 1997
CERTAIN COMPLETE LEVELS 1,2, AND 3
K970956 · JJY
Chiron Diagnostics Corp.
Chemistry · 22d
Cleared Apr 08, 1997
DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)
K971058 · DIF
Medical Analysis Systems, Inc.
Chemistry · 15d
Cleared Apr 04, 1997
CLINITEK HCG TEST STRIPS
K971209 · JHI
Bayer Corp.
Chemistry · 2d
Cleared Apr 02, 1997
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
K970701 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 35d
Cleared Apr 02, 1997
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
K970976 · JJY
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Apr 02, 1997
LIQUID CSF(LCR)1, LIQUID CSF(LCR)2
K970979 · JJY
Chiron Diagnostics Corp.
Chemistry · 16d
Cleared Apr 02, 1997
THE ELECSYS CALCHECK PROGESTERONE
K970984 · JJX
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Mar 28, 1997
PARAMAX TRIGLYCERID REAGENT
K964346 · CDT
Dade Intl., Inc.
Chemistry · 148d