Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
1057–1080 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 18, 2013
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
K132418 · JGS
Roche Diagnostics
Chemistry · 138d
Cleared Dec 12, 2013
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132862 · NBW
Infopia Co, Ltd.
Chemistry · 91d
Cleared Dec 05, 2013
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE...
K132966 · NBW
Infopia Co, Ltd.
Chemistry · 76d
Cleared Dec 04, 2013
ELECSYS CALCITONIN
K132828 · JKR
Roche Diagnostics
Chemistry · 86d
Cleared Nov 26, 2013
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM...
K133330 · JIX
Roche Diagnostics
Chemistry · 25d
Cleared Nov 26, 2013
PRODIGY CHOICE
K122340 · NBW
Prodigy Diabetes Care, LLC
Chemistry · 481d
Cleared Nov 22, 2013
ELECSYS CK-MB CALCHECK 5
K133284 · JJX
Roche Diagnostics
Chemistry · 28d
Cleared Nov 22, 2013
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
K133067 · CDT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Nov 22, 2013
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE...
K132288 · NBW
I-Sens, Inc.
Chemistry · 122d
Cleared Nov 22, 2013
GLB BENECHECK PREMIUM GLU MONITORING SYSTEM
K123090 · NBW
General Life Biotechnology Co., Ltd.
Chemistry · 417d
Cleared Nov 21, 2013
INFLAMMA DRY
K132066 · PFQ
Rapid Pathogen Screening, Inc.
Chemistry · 141d
Cleared Nov 21, 2013
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
K123977 · CGS
Randox Laboratories, Ltd.
Chemistry · 330d
Cleared Nov 20, 2013
AGAMATRIX HEALTH MANAGER
K132821 · NBW
Agamatrix, Inc.
Chemistry · 72d
Not Cleared Nov 19, 2013
MISEQDX UNIVERSAL KIT 1.0
DEN130042 · PFT
Illumina, Inc.
Chemistry · 46d
Not Cleared Nov 19, 2013
ILLUMINA MISEQDX PLATFORM
DEN130011 · PFF
Illumina, Inc.
Chemistry · 57d
Cleared Nov 14, 2013
GSP NEONATAL BIOTINIDASE KIT
K131284 · NAK
Wallac OY
Chemistry · 192d
Cleared Nov 12, 2013
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
K132085 · LCX
Co-Innovation Biotech Co., Ltd.
Chemistry · 130d
Cleared Nov 08, 2013
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
K132515 · CEW
DiaSorin, Inc.
Chemistry · 88d
Cleared Nov 07, 2013
UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST,...
K131236 · LCX
Ucp Biosciences, Inc.
Chemistry · 190d
Cleared Nov 06, 2013
UNISTRIP 1
K113135 · NBW
Unistrip Technologies, LLC
Chemistry · 744d
Cleared Nov 05, 2013
PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
K122338 · NBW
Prodigy Diabetes Care, LLC
Chemistry · 460d
Cleared Oct 28, 2013
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
K132462 · CDN
Hitachi Chemical Diagnostics, Inc.
Chemistry · 82d
Cleared Oct 25, 2013
IMMULITE 2000
K133124 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 25d
Cleared Oct 25, 2013
LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM...
K132227 · JJY
Bio-Rad Laboratories
Chemistry · 100d