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
8017–8040 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 11, 1988
IRON PROCEDURE
K874918 · JIY
Data Medical Associates, Inc.
Chemistry · 70d
Cleared Feb 11, 1988
LEECO PREGNASTICK (EIA) CATALOG #003
K880069 · LCX
Leeco Diagnostics, Inc.
Chemistry · 31d
Cleared Feb 11, 1988
UREA NITROGEN (BUN)
K880078 · CDQ
Tech-Neal Scientific, Inc.
Chemistry · 31d
Cleared Feb 11, 1988
FINNIGAN MAT TSQ-70
K880089 · DOP
Finnigan Corp.
Chemistry · 30d
Cleared Feb 08, 1988
KODAK SURECELL(TM) HCG-URINE KIT
K874388 · JHI
Eastman Kodak Company
Chemistry · 104d
Cleared Feb 08, 1988
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0
K874857 · JJE
Eastman Kodak Company
Chemistry · 75d
Cleared Feb 08, 1988
ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R)
K875263 · JGS
Technicon Instruments Corp.
Chemistry · 48d
Cleared Feb 03, 1988
BIOTROL CALIBRANT LEVEL 2
K875304 · JIX
Biotrol, USA, Inc.
Chemistry · 36d
Cleared Feb 02, 1988
GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM
K870708 · LFR
Kyoto Daiichi Kagaku Co., Ltd.
Chemistry · 347d
Cleared Feb 02, 1988
OVEIA (TM) DUAL ANALYTE
K872843 · JLP
Boots-Celltech Diagnostics, Inc.
Chemistry · 197d
Cleared Feb 02, 1988
BETA-HCG ASSAY
K873986 · DHA
Schiff & Co.
Chemistry · 126d
Cleared Feb 02, 1988
MODIFIED CALCITONIN RIA KIT DSL #1200
K874087 · JKR
Diagnostic Systems Laboratories, Inc.
Chemistry · 118d
Cleared Feb 02, 1988
QUANTIMETRIX TOTAL CREATINE KINASE CONTROL
K874302 · JJT
Quantimetrix Medical Industries
Chemistry · 105d
Cleared Feb 02, 1988
WAKO(TM) UIBC
K875176 · JQF
Wako Chemicals USA, Inc.
Chemistry · 47d
Cleared Feb 02, 1988
LACTATE DEHYDROGENASE CAT. # 320-68, 320-69
K875206 · CFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Feb 02, 1988
ALKALINE PHOSPHATASE CAT. # 306-22, 306-23
K875210 · CJE
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Feb 02, 1988
V-TREND BETA-HCG DRY-SPOT TEST
K875262 · JHJ
Texas Immunology, Inc.
Chemistry · 42d
Cleared Feb 02, 1988
BIOTROL CALIBRANT LEVEL 1
K875288 · JIX
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Feb 02, 1988
BIOTROL CALIBRANT LEVEL 3
K875318 · JIX
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Feb 01, 1988
ACID PHOSPHATASE (KINETIC) CAT. # 320-06
K875209 · CKB
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 45d
Cleared Feb 01, 1988
BIOTROL URIC ACID ENZYMATIQUE UV H.P.
K875320 · CDO
Biotrol, USA, Inc.
Chemistry · 34d
Cleared Jan 27, 1988
ACID PHOSPHATASE TEST
K873726 · CKE
King Diagnostics, Inc.
Chemistry · 134d
Cleared Jan 22, 1988
USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R)
K874506 · JGJ
Technicon Instruments Corp.
Chemistry · 81d
Cleared Jan 22, 1988
TOTAL PROTEIN
K875222 · CEK
Catachem, Inc.
Chemistry · 31d