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
9673–9696 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 17, 1984
DOUMENT TM LINEARITY TEST STANDARDS
K843947 · JIX
Casco Standards
Chemistry · 8d
Cleared Oct 11, 1984
DIAGEM DIGITAL BLOOD GLUCOSE MONITOR
K841648 · JJQ
Forward Medical Supplies
Chemistry · 174d
Cleared Oct 11, 1984
GASTRIN RADIOIMMUNOASSAY TEST KIT
K842965
Serono Diagnostics, Inc.
Chemistry · 76d
Cleared Oct 11, 1984
RENIN RADIOIMMUNOASSAY TEST KIT
K842966 · CIB
Serono Diagnostics, Inc.
Chemistry · 76d
Cleared Oct 11, 1984
ATAC 2000
K843059 · JJE
Turpen Laboratory Systems, Inc.
Chemistry · 69d
Cleared Oct 11, 1984
ENCORE TSH REAGENT
K843395 · JLW
Hybritech, Inc.
Chemistry · 43d
Cleared Oct 11, 1984
ASTRA SYSTEMS AMYLASE REAGENT KIT
K843529 · CJA
Beckman Instruments, Inc.
Chemistry · 34d
Cleared Oct 11, 1984
TRIGLYCERIDE ASSAY KIT GPO-CP
K843536 · CDT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 34d
Cleared Oct 11, 1984
C-TERMINAL/MID-MOLECULE PARATHYROID -
K843685 · CEW
Nichols Institute Diagnostics
Chemistry · 23d
Cleared Oct 11, 1984
ALBUMIN REAGENT SET
K843831 · CIX
Livonia Diagnostics, Inc.
Chemistry · 10d
Cleared Oct 05, 1984
STANDARDS & ACCESSORIES FOR NOVA INSTRU
K842873 · JGS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 74d
Cleared Oct 05, 1984
ROCHE REAGENT FOR ALT
K843111 · CKA
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Oct 05, 1984
BOEHRINGER MANNHEIM DIAGNOSTICS ADAM
K843283 · JJE
Boehringer Mannheim Corp.
Chemistry · 46d
Cleared Oct 05, 1984
ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.
K843434 · JQC
Iso-Data, Inc.
Chemistry · 31d
Cleared Oct 05, 1984
KOVA TROL I,II, III HUMAN URINE-DRIED
K843565 · JJW
Icl Scientific
Chemistry · 25d
Cleared Oct 05, 1984
PERSPECTIVE CHEMICAL ANALYZER
K843610 · JJE
American Monitor Corp.
Chemistry · 22d
Cleared Oct 05, 1984
CORNING IMMUNOFIXATION SYS
K843614 · CZP
Corning Medical & Scientific
Chemistry · 21d
Cleared Oct 05, 1984
HUMAN SERUM CARDIOACTIVE DRUG CONTROL
K843679 · DIF
Quantimetrix Corp.
Chemistry · 17d
Cleared Oct 05, 1984
SCLAVO CHLORIDE TEST
K843740 · CHJ
Sclavo, Inc.
Chemistry · 10d
Cleared Oct 04, 1984
ENCORE HCG REAGENT
K843407 · JHI
Hybritech, Inc.
Chemistry · 34d
Cleared Oct 02, 1984
TSH QUIK RIA KIT
K843545 · JLW
Pacific Biotech, Inc.
Chemistry · 22d
Cleared Oct 01, 1984
TOTAL PROTEIN REAGENT SET
K843701 · CEK
Livonia Diagnostics, Inc.
Chemistry · 10d
Cleared Sep 28, 1984
H.P.T. HOME PREG. TEST KIT & A.P.T.
K834474 · LCX
Biomedical Research & Development...
Chemistry · 283d
Cleared Sep 28, 1984
ISO-SEP SYSTEM
K842018 · CEX
Berwick Medical Products, Inc.
Chemistry · 133d