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
6121–6144 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 09, 1992
SYSTEMATE CREATININE TEST
K923203 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Sep 09, 1992
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
K923267 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Sep 09, 1992
AMYLASE TEST
K923677 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Sep 02, 1992
MONI-TROL-L AND MONI-TROL-XL
K920291 · JJY
Medical Analysis Systems, Inc.
Chemistry · 224d
Cleared Sep 02, 1992
COTUBE PTH IRMA
K921949 · CEW
Bio-Rad
Chemistry · 128d
Cleared Sep 02, 1992
LABOTECH AUTOMATED MICROTITER ANALYZER
K922081 · JJQ
Innovative Medical Systems, Inc.
Chemistry · 120d
Cleared Sep 02, 1992
AMERLITE PROLACTIN-30 ASSAY
K922170 · CFT
Eastman Kodak Company
Chemistry · 117d
Cleared Sep 02, 1992
TOTAL T3 CHEMILUMINESCENCE ASSAY
K923015 · CDP
Nichols Institute Diagnostics
Chemistry · 72d
Cleared Sep 01, 1992
SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD
K923090 · JKA
Ryan Medical, Inc.
Chemistry · 68d
Cleared Aug 28, 1992
ABL50 BLOOD GAS SYSTEM
K922922 · CHL
Radiometer America, Inc.
Chemistry · 72d
Cleared Aug 26, 1992
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT
K923569 · JMO
Baxter Diagnostics, Inc.
Chemistry · 40d
Cleared Aug 24, 1992
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
K922913 · LBZ
Syva Co.
Chemistry · 68d
Cleared Aug 24, 1992
MILES POTASSIUM METHOD
K923038 · CEM
Heraeus Kulzer, Inc.
Chemistry · 66d
Cleared Aug 24, 1992
MILES URINE CREATININE METHOD
K923039 · CGX
Heraeus Kulzer, Inc.
Chemistry · 66d
Cleared Aug 20, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
K922700 · JHY
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 77d
Cleared Aug 19, 1992
ARRAY(R) 360
K922273 · JQX
Beckman Instruments, Inc.
Chemistry · 97d
Cleared Aug 18, 1992
QUICK-CHECK II REAGENT STRIP
K921825 · CGA
Diagnostic Solutions, Inc.
Chemistry · 124d
Cleared Aug 18, 1992
REP SPE PLUS (PONCEAU S) SYSTEM
K922053 · CEF
Helena Laboratories
Chemistry · 106d
Cleared Aug 18, 1992
UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311
K922770 · MQM
Leica, Inc.
Chemistry · 70d
Cleared Aug 18, 1992
KING DIAGNOSTIC TRIGLYCERIDES REAGENT
K922964 · CDT
King Diagnostics, Inc.
Chemistry · 60d
Cleared Aug 18, 1992
OLYMPUS MAGNESIUM REAGENT
K923411 · JGJ
Olympus Corp.
Chemistry · 39d
Cleared Aug 18, 1992
OLYMPUS INORGANIC PHOSPHORUS REAGENT
K923564 · CEO
Olympus Corp.
Chemistry · 32d
Cleared Aug 18, 1992
OLYMPUS DIRECT BILIRUBIN REAGENT
K923608 · CIG
Olympus Corp.
Chemistry · 34d
Cleared Aug 12, 1992
VACU-PRO
K922445 · JKA
Concord/Portex
Chemistry · 82d