FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
10753–10776 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 29, 1982
ENZYME-TEST DIGOXIN
K823199 · KXT
Icl Scientific
Chemistry · 34d
Cleared Nov 29, 1982
125 I-DEHYDROEPIANDROSTERONE SULFATE
K823200 · JKC
Wien Laboratories, Inc.
Chemistry · 34d
Cleared Nov 29, 1982
HUMAN PLACENTAL LACTOGEN KIT
K823201 · JMF
Diagnostic Products Corp.
Chemistry · 34d
Cleared Nov 29, 1982
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
K823212 · DJP
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Nov 29, 1982
SBA 300 CLINICAL CHEMISTRY ANALYZER
K823233 · JJC
Gilford Instrument Laboratories, Inc.
Chemistry · 31d
Cleared Nov 27, 1982
SARTOPHOR SYSTEM FOR ELECTROPHORESIS
K823132 · JJN
Sartorius Filters, Inc.
Chemistry · 33d
Cleared Nov 22, 1982
HEMOGLOBIN REAGENT
K823060 · KHG
Biorent Diagnostic, Inc.
Chemistry · 35d
Cleared Nov 22, 1982
RAICHEM & GT REAGENT
K823090 · JPZ
Reagents Applications, Inc.
Chemistry · 34d
Cleared Nov 22, 1982
URIC ACID STANDARD, 8MG/DL #65078
K823147 · JIS
Harleco Diagnostics
Chemistry · 28d
Cleared Nov 22, 1982
CHOLESTEROL HIGH SENSIT. REAGENT ENZYM
K823187 · CHH
Rai, Inc.
Chemistry · 27d
Cleared Nov 22, 1982
CK-UV REAGENT
K823211 · JHS
Biorent Diagnostic, Inc.
Chemistry · 25d
Cleared Nov 22, 1982
DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI
K823213 · CJE
Boehringer Mannheim Corp.
Chemistry · 25d
Cleared Nov 18, 1982
BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA
K823087 · CKB
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared Nov 16, 1982
MICROFLUOR B PLATE & MICRO FLUOR W PLATE
K822960 · LIB
Dynatech Corp.
Chemistry · 42d
Cleared Nov 16, 1982
MICROFLUOR B REMOVAWELL STRIPS
K822962 · LIB
Dynatech Corp.
Chemistry · 42d
Cleared Nov 16, 1982
HYPOCOUNT A
K822976 · CGA
Pharmaquest Corp.
Chemistry · 39d
Cleared Nov 16, 1982
KM-KAL 3
K823019 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
KM-KAL 4
K823020 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
KM - KAL 5
K823021 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
KM-KAL 6
K823022 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
KM-KAL L6
K823023 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
KM - KAL 1
K823024 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
KM - KAL 2
K823025 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
RERMCO TEST CHLORIDE REAGENT
K823106 · JFS
Fermco Biochemics, Inc.
Chemistry · 26d