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
3889–3912 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 19, 1999
SAS HCG SERUM CONTROLS
K990720 · JJX
Sa Scientific, Inc.
Chemistry · 14d
Cleared Mar 18, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02
K990394 · JJY
Bio-Rad
Chemistry · 37d
Cleared Mar 18, 1999
ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01
K990317 · JJY
Bio-Rad
Chemistry · 48d
Cleared Mar 18, 1999
CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000
K990036 · JGS
Careside, Inc.
Chemistry · 71d
Cleared Mar 18, 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER
K984006 · CGA
Bayer Corp.
Chemistry · 128d
Cleared Mar 16, 1999
CARESIDE AST
K990009 · CIT
Careside, Inc.
Chemistry · 71d
Cleared Mar 15, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01
K990391 · JJY
Bio-Rad
Chemistry · 34d
Cleared Mar 12, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS
K990531 · JJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Mar 09, 1999
OSOM CARD II HCG-URINE TEST, MODEL 102
K990578 · JHI
Wyntek Diagnostics, Inc.
Chemistry · 14d
Cleared Mar 09, 1999
OSOM CARD PREGNANCY TEST, MODEL 103
K990576 · LCX
Wyntek Diagnostics, Inc.
Chemistry · 14d
Cleared Mar 09, 1999
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
K990282 · JJY
Bio-Rad
Chemistry · 39d
Cleared Mar 09, 1999
WAKO AUTOKIT LP(A)
K981446 · DFC
Wako Chemicals USA, Inc.
Chemistry · 321d
Cleared Mar 04, 1999
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K983071 · MQM
Respironics, Inc.
Chemistry · 183d
Cleared Feb 26, 1999
IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6
K990222 · DHA
Diagnostic Products Corp.
Chemistry · 32d
Cleared Feb 26, 1999
MTM BIOSCANNER K TEST STRIPS
K981865 · JMK
Polymer Technology Systems, Inc.
Chemistry · 274d
Cleared Feb 24, 1999
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR
K990223 · NGE
Unipath , Ltd.
Chemistry · 30d
Cleared Feb 22, 1999
FACT PLUS ONE STEP PREGNANCY TEST
K990373 · LCX
Abbott Laboratories
Chemistry · 14d
Cleared Feb 16, 1999
MAGNETIC TIBC KIT
K990216 · JMO
Reference Diagnostics, Inc.
Chemistry · 25d
Cleared Feb 16, 1999
QUANTASE PHE/GAL SCREENING ASSAY
K984463 · JNB
Quantase , Ltd.
Chemistry · 62d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST
K984080 · JHI
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST
K984079 · JHI
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY COMBO TEST
K984077 · JHI
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY URINE TEST
K984076 · JHI
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST
K984075 · LCX
Alfa Scientific Designs, Inc.
Chemistry · 92d