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
8665–8688 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 05, 1986
SMI MULTIPETTOR(TM)
K863887 · JQW
American Dade
Chemistry · 30d
Cleared Oct 29, 1986
CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95
K863478 · JGQ
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Oct 29, 1986
SERACON CT REFERENCE
K863648 · JJY
Bhp Diagnostix, Inc.
Chemistry · 41d
Cleared Oct 29, 1986
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95
K863660 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 41d
Cleared Oct 29, 1986
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95
K863718 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Oct 29, 1986
URIC ACID TEST
K864119 · KNK
U. S. Diagnostics, Inc.
Chemistry · 8d
Cleared Oct 24, 1986
BLOOD SPECIMEN COLLECTION DEVICES
K863491 · JKA
Medelec Intl. Corp.
Chemistry · 46d
Cleared Oct 24, 1986
ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)
K863617 · JGS
Hi Chem, Inc.
Chemistry · 38d
Cleared Oct 24, 1986
OCEAN SCIENTIFIC VACUTEST
K863976 · JKA
Ocean Scientific, Inc.
Chemistry · 10d
Cleared Oct 21, 1986
SOLUTION B- NA 50MEQ/L, K 40 MEQ/L
K863502 · JIX
Reagent Laboratory, Inc.
Chemistry · 42d
Cleared Oct 21, 1986
ULTRAWASH I
K863623 · JQW
Dynatech Laboratories, Inc.
Chemistry · 35d
Cleared Oct 21, 1986
ULTRAWASH II
K863624 · JQW
Dynatech Laboratories, Inc.
Chemistry · 35d
Cleared Oct 20, 1986
TECHNICON RA-XT SYSTEM WITH ANALYTES
K862561 · JJC
Technicon Instruments Corp.
Chemistry · 109d
Cleared Oct 20, 1986
IQ IMMUNOCHEMISTRY SYSTEM
K863531 · JJE
Bd Becton Dickinson Vacutainer...
Chemistry · 40d
Cleared Oct 16, 1986
GSC 1000
K863566 · JJQ
Genetic Systems Corp.
Chemistry · 34d
Cleared Oct 16, 1986
CHLORIDE PROCEDURE
K863585 · CHJ
Data Medical Associates, Inc.
Chemistry · 31d
Cleared Oct 16, 1986
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM
K863678 · CGJ
Nichols Institute Diagnostics
Chemistry · 27d
Cleared Oct 16, 1986
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K863679 · CEP
Nichols Institute Diagnostics
Chemistry · 27d
Cleared Oct 16, 1986
ACID PHOSPHATASE (ACP) REAGENT
K863851 · CKB
Sigma Diagnostics, Inc.
Chemistry · 14d
Cleared Oct 14, 1986
CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)
K862233 · KLI
Ciba Corning Diagnostics Corp.
Chemistry · 125d
Cleared Oct 10, 1986
HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS
K854236 · IAF
Nms Pharmaceuticals, Inc.
Chemistry · 354d
Cleared Oct 07, 1986
PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT
K862447 · KHQ
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 102d
Cleared Oct 07, 1986
ABNORMAL SPINAL FLUID CONTROL
K863745 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 13d
Cleared Oct 03, 1986
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
K861255 · JIL
Behring Diagnostics, Inc.
Chemistry · 183d