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
9745–9768 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 13, 1984
SYSTEMATE ALKALINE PHOSPHATASE-67203
K843270 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
ELVI 675 DIGITRON
K843296 · JJQ
Logos Scientific, Inc.
Chemistry · 23d
Cleared Sep 13, 1984
SYSTEMATE URIC ACID, HEM 67220
K843325 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 12, 1984
OXALATE URINE CONTROLS NORMAL & ELEVAT
K842366 · JJW
Sigma Chemical Co.
Chemistry · 89d
Cleared Sep 12, 1984
SUCROSEP THYROID STIMULATING HORMONE
K842593 · JLW
Boots-Celltech Diagnostics, Inc.
Chemistry · 71d
Cleared Sep 12, 1984
AMIKACIN ANALYTICAL TEST PACK ACA
K843211 · KLQ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 28d
Cleared Sep 10, 1984
ELVI 146 SEROSCAN
K842313 · JQT
Logos Scientific, Inc.
Chemistry · 90d
Cleared Sep 07, 1984
DIATROL BLOOD GLUCOSE TEST SYS
K842684 · CGA
Bd Becton Dickinson Vacutainer...
Chemistry · 59d
Cleared Sep 07, 1984
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT
K842694 · KHQ
Terumo Medical Corp.
Chemistry · 58d
Cleared Sep 07, 1984
CODE-A-WELL 350 MICROTITRATION STRIPS
K842848 · JTC
Plastic Injectors, Inc.
Chemistry · 49d
Cleared Sep 07, 1984
CARDI-CK EIA TEST KIT CK-MB ISOENZYME
K843007 · JHS
Intl. Immunoassay Laboratories, Inc.
Chemistry · 38d
Cleared Sep 07, 1984
ALBUMIN ASSAY KIT
K843104 · CIX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 31d
Cleared Sep 07, 1984
TOTAL BILIRUBIN TEST
K843178 · CIG
Sclavo, Inc.
Chemistry · 25d
Cleared Sep 07, 1984
CREATININE TEST
K843179 · CGX
Sclavo, Inc.
Chemistry · 25d
Cleared Sep 07, 1984
SYSTEMATE CK-TOTAL - 67206
K843271 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 06, 1984
C-PEP-RIA-100
K842267 · JKD
Institut National Des Radioelements
Chemistry · 90d
Cleared Sep 05, 1984
QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT
K842692 · JHI
Quidel Corp.
Chemistry · 56d
Cleared Sep 05, 1984
CALCITONIN RADIOIMMUNOASSAY KIT
K842907 · JKR
Nichols Institute Diagnostics
Chemistry · 43d
Cleared Sep 05, 1984
AMERLEX-M FREE T-3 RIA
K842949 · CDP
Amersham Corp.
Chemistry · 61d
Cleared Sep 04, 1984
CORNING MAGIC CORTISOL RADIOIMMUNO
K841641 · CGR
Corning Medical & Scientific
Chemistry · 137d
Cleared Sep 04, 1984
CHEMISTRY CONSOLE
K842401 · JQP
Biovation, Inc.
Chemistry · 77d
Cleared Sep 04, 1984
LH RIA
K842445 · CEP
Syncor Intl. Corp.
Chemistry · 75d
Cleared Sep 04, 1984
LABSYSTEMS FP-901 CHEMISTRY ANALYZER
K842773 · JJE
Labsystems, Inc.
Chemistry · 50d
Cleared Sep 04, 1984
AMERLEX-M TSH RIA
K842948 · JLW
Amersham Corp.
Chemistry · 40d