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
3985–4008 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 30, 1998
TERUMO VENOJECT,LUER ADAPTER
K983490 · JKA
Terumo Corp.
Chemistry · 56d
Cleared Nov 25, 1998
ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
K984073 · JJX
Bio-Rad
Chemistry · 9d
Cleared Nov 25, 1998
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
K984070 · JJX
Bio-Rad
Chemistry · 9d
Cleared Nov 25, 1998
IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
K983970 · DDR
Diagnostic Products Corp.
Chemistry · 16d
Cleared Nov 25, 1998
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K983726 · LCP
Genzyme Corp.
Chemistry · 34d
Cleared Nov 25, 1998
PRECISET SERUM PROTEINS CALIBRATOR
K983469 · JIX
Boehringer Mannheim Corp.
Chemistry · 55d
Cleared Nov 25, 1998
ABBOTT ARCHITECT TOTAL T4
K983440 · KLI
Abbott Laboratories
Chemistry · 57d
Cleared Nov 24, 1998
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
K984072 · JJX
Bio-Rad
Chemistry · 8d
Cleared Nov 20, 1998
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
K984074 · JJY
Bio-Rad
Chemistry · 4d
Cleared Nov 20, 1998
ABBOTT ARCHITECT TSH
K983442 · JLW
Abbott Laboratories
Chemistry · 51d
Cleared Nov 20, 1998
ABBOTT ARCHITECT FREE T3
K983439 · CDP
Abbott Laboratories
Chemistry · 52d
Cleared Nov 20, 1998
ABBOTT ARCHITECT TOTAL T3
K983434 · CDP
Abbott Laboratories
Chemistry · 52d
Cleared Nov 20, 1998
ABBOTT ARCHITECT FREE T4
K983417 · CEC
Abbott Laboratories
Chemistry · 52d
Cleared Nov 18, 1998
CARDIAC MARKER CONTROL MODULE, MODEL CCCM
K983971 · JJX
Diagnostic Products Corp.
Chemistry · 9d
Cleared Nov 18, 1998
DIMENSION AHDL CALIBRATOR
K983850 · JIT
Dade Behring, Inc.
Chemistry · 19d
Cleared Nov 18, 1998
ABBOTT ARCHITECT TESTOSTERONE
K983212 · CDZ
Abbott Laboratories
Chemistry · 65d
Cleared Nov 18, 1998
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
K983113 · CEP
Syntron Bioresearch, Inc.
Chemistry · 75d
Cleared Nov 18, 1998
ACON MIDSTREAM PREGNANCY TEST
K983090 · LCX
ACON Laboratories, Inc.
Chemistry · 76d
Cleared Nov 16, 1998
ABBOTT AXSYM MYOGLOBIN
K983848 · DDR
Abbott Laboratories
Chemistry · 17d
Cleared Nov 16, 1998
25-HYDROXYVITAMIN D 125I RIA KIT
K983617 · LCI
DiaSorin, Inc.
Chemistry · 32d
Cleared Nov 12, 1998
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
K983578 · JJX
Bio-Rad
Chemistry · 30d
Cleared Nov 12, 1998
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
K983517 · JKA
Ram Scientific
Chemistry · 36d
Cleared Nov 04, 1998
STRATUS CS TROPONIN I CALIBRATOR
K983722 · JIT
Dade Behring, Inc.
Chemistry · 14d
Cleared Nov 04, 1998
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
K983693 · JIT
Dade Behring, Inc.
Chemistry · 14d