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
8449–8472 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 13, 1987
CHOLESTEROL DETERMINATION
K871260 · CHH
Biochemical Trade, Inc.
Chemistry · 13d
Cleared Apr 13, 1987
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)
K871269 · JFJ
Technicon Instruments Corp.
Chemistry · 13d
Cleared Apr 08, 1987
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY
K870521 · JHI
Hybritech, Inc.
Chemistry · 61d
Cleared Apr 08, 1987
FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339
K871284 · JIY
American Research Products Co.
Chemistry · 8d
Cleared Apr 07, 1987
MODIFICATION OF ACCU-CHEK II
K863481 · CGA
Boehringer Mannheim Corp.
Chemistry · 210d
Cleared Apr 07, 1987
TRIGLYCERIDES DETERMINATION
K871122 · CDT
Biochemical Trade, Inc.
Chemistry · 18d
Cleared Apr 06, 1987
LIQUID CHEMISTRY CONTROL, LEVEL II
K870683 · JJY
U. S. Diagnostics, Inc.
Chemistry · 46d
Cleared Apr 06, 1987
LIQUID CHEMISTRY CONTROL, LEVEL I
K870684 · JJY
U. S. Diagnostics, Inc.
Chemistry · 46d
Cleared Apr 06, 1987
SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN)
K871058 · JJY
Fisher Scientific Co., LLC
Chemistry · 20d
Cleared Apr 01, 1987
IQ TSH IMMUNOASSAY
K870244 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 70d
Cleared Apr 01, 1987
AUTOPAK TSH MONOCLONAL IRMA KIT
K870245 · JLW
Micromedic Systems
Chemistry · 70d
Cleared Apr 01, 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD
K870672 · JHI
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 41d
Cleared Apr 01, 1987
CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY
K870833 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 29d
Cleared Apr 01, 1987
ATAC 1500 CHEMISTRY ANALYZER
K870836 · JJE
Turpen Laboratory Systems, Inc.
Chemistry · 29d
Cleared Mar 31, 1987
BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS
K870115 · JJJ
Berthold Analytical Instruments, Inc.
Chemistry · 78d
Cleared Mar 31, 1987
ABBOTT SPECTRUM AMMONIA REAGENT
K870787 · JIF
Abbott Laboratories
Chemistry · 33d
Cleared Mar 19, 1987
STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.
K870158 · CEC
American Dade
Chemistry · 65d
Cleared Mar 19, 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR
K870673 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 28d
Cleared Mar 19, 1987
CENTRIPREP CONCENTRATOR
K870690 · JJH
Amicon, Inc.
Chemistry · 28d
Cleared Mar 19, 1987
EASY-TEST URIC ACID (URIC) #16606
K870868 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Mar 19, 1987
ALANINE TRANSAMINASE (ALT) TEST KIT
K870879 · CKA
Genetic Systems Corp.
Chemistry · 15d
Cleared Mar 17, 1987
DACOMED PENILE PROSTHESIS SIZER
K870320 · JLW
Dacomed Corp.
Chemistry · 48d
Cleared Mar 16, 1987
STAVIP 3000
K864436 · JJN
Roseburg SA
Chemistry · 124d
Cleared Mar 16, 1987
RESUBMISSION OF THE KLEERZIT REAGENT
K864866 · JKA
Advanced Biomedical Methods, Inc.
Chemistry · 95d