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
7681–7704 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 15, 1988
AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030
K881056 · JJC
American Research Products Co.
Chemistry · 249d
Cleared Nov 10, 1988
CREATINE KINASE (CK) ISOENZYME MB
K881168 · JHT
Data Medical Associates, Inc.
Chemistry · 237d
Cleared Nov 10, 1988
HYGEIA URINE PREGNANCY TEST
K882192 · DHA
Hygeia Sciences
Chemistry · 169d
Cleared Nov 10, 1988
PROBE(TM) MODELS 700 AND 1000
K883749 · JQW
Packard Instrument Co., Inc.
Chemistry · 70d
Cleared Nov 10, 1988
CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE
K883813 · JKA
Ciba Corning Diagnostics Corp.
Chemistry · 63d
Cleared Nov 10, 1988
MAGNESIUM REAGENT (MAGON SULFONATE)
K883972 · JGJ
Sigma Chemical Co.
Chemistry · 51d
Cleared Nov 10, 1988
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
K884021 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Nov 10, 1988
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
K884100 · JLS
Amersham Corp.
Chemistry · 43d
Cleared Nov 10, 1988
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
K884548 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Nov 10, 1988
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
K884549 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Nov 08, 1988
DIMENSION WHOLE BLOOD CHOLESTEROL
K880723 · CHH
Technimed, Inc.
Chemistry · 259d
Cleared Nov 04, 1988
CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY
K883722 · CDD
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Nov 01, 1988
CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18
K880868 · KHS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 245d
Cleared Nov 01, 1988
IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES
K883747 · CFT
Diagnostic Products Corp.
Chemistry · 61d
Cleared Nov 01, 1988
AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)
K883878 · CFT
Amersham Corp.
Chemistry · 49d
Cleared Oct 31, 1988
ONE-STEP HCG
K882896 · DHA
Wampole Laboratories
Chemistry · 112d
Cleared Oct 31, 1988
IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)
K883267 · CDZ
Diagnostic Products Corp.
Chemistry · 89d
Cleared Oct 31, 1988
SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER
K883539 · JJE
Serono-Baker Diagnostics, Inc.
Chemistry · 76d
Cleared Oct 31, 1988
BEHRING TURBITIMER
K883646 · JJQ
Behring Diagnostics, Inc.
Chemistry · 67d
Cleared Oct 31, 1988
TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE
K883765 · KHQ
Biotecx Laboratories, Inc.
Chemistry · 55d
Cleared Oct 31, 1988
HI CHEM KINETIC CHOLESTEROL REAGENT #88218
K883844 · CHH
Hichem Diagnostics
Chemistry · 49d
Cleared Oct 27, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
K884147 · DFT
Orion Diagnostica, Inc.
Chemistry · 24d
Cleared Oct 25, 1988
BILIRUBIN STANDARD
K882059 · JIT
Verichem Laboratories, Inc.
Chemistry · 162d
Cleared Oct 25, 1988
DISCOVER(R)
K882232 · LCX
Carter Products
Chemistry · 151d