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
3841–3864 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 28, 1999
VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND...
K991088 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 57d
Cleared May 28, 1999
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
K990247 · LBR
Polymer Technology Systems, Inc.
Chemistry · 122d
Cleared May 25, 1999
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR...
K991466 · CEP
Selfcare, Inc.
Chemistry · 28d
Cleared May 25, 1999
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK),...
K991386 · CEP
Selfcare, Inc.
Chemistry · 34d
Cleared May 25, 1999
URIC ACID, MODEL UA112-01
K991247 · KNK
A.P. Total Care, Inc.
Chemistry · 43d
Cleared May 25, 1999
TOTAL IRON, MODELS FE 109-01, FE 109-02
K991244 · JMO
A.P. Total Care, Inc.
Chemistry · 43d
Cleared May 25, 1999
BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO....
K991111 · CIC
A.P. Total Care, Inc.
Chemistry · 54d
Cleared May 25, 1999
CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
K991109 · CGX
A.P. Total Care, Inc.
Chemistry · 54d
Cleared May 25, 1999
CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
K991108 · KHS
A.P. Total Care, Inc.
Chemistry · 54d
Cleared May 25, 1999
GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL...
K990981 · CFR
A.P. Total Care, Inc.
Chemistry · 63d
Cleared May 25, 1999
BUN, MODEL BU 104-01
K990980 · CDQ
A.P. Total Care, Inc.
Chemistry · 63d
Cleared May 25, 1999
ALBUMIN BCG, MODEL AL 103-01
K990978 · CJW
A.P. Total Care, Inc.
Chemistry · 63d
Cleared May 21, 1999
BAYER ADVIA 1650 CHEMISTRY SYSTEM
K990346 · JGS
Bayer Corp.
Chemistry · 106d
Cleared May 21, 1999
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K984261 · CGA
Lifescan, Inc.
Chemistry · 175d
Cleared May 19, 1999
ELAN ALKALINE PHOSPHATE REAGENT KIT
K991387 · CJE
Elan Holdings, Inc.
Chemistry · 28d
Cleared May 19, 1999
MODIFICATION OF N/T PROTEIN CONTROL SL
K991182 · JJY
Dade Behring, Inc.
Chemistry · 42d
Cleared May 19, 1999
VACUTAINER BRAND CTAD TUBE (MULTIPLE)
K991120 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 47d
Cleared May 19, 1999
ACP
K991010 · CKB
Abbott Diagnostics Mfg., Inc.
Chemistry · 54d
Cleared May 11, 1999
AIA-PACK FT3 ASSAY
K991252 · CDP
Tosoh Medics, Inc.
Chemistry · 28d
Cleared May 11, 1999
CALCITONIN
K990073 · JKR
Kmi Diagnostics, Inc.
Chemistry · 120d
Cleared May 10, 1999
ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
K991369 · LCX
Germaine Laboratories, Inc.
Chemistry · 20d
Cleared May 10, 1999
ATLAST GLUCOSE CONTROL SOLUTION
K991075 · JJX
Amira Medical, Inc.
Chemistry · 40d
Cleared May 10, 1999
SAS ONE-STEP PREGNANCY
K990741 · JHI
Sa Scientific, Inc.
Chemistry · 63d
Cleared May 10, 1999
MODIFICATION OF SAS SERUM/URINE HCG
K990684 · JHI
Sa Scientific, Inc.
Chemistry · 68d