FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,234 results
1033–1056 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 19, 2013
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K132086 · NBW
ACON Laboratories, Inc.
Chemistry · 167d
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