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
7657–7680 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 09, 1988
MODIFIED CEDIA TOTAL T4 ASSAY
K884634 · KLI
Microgenics Corp.
Chemistry · 32d
Cleared Dec 06, 1988
ABBOTT A-GENT LIPASE REAGENT
K884596 · CHI
Abbott Laboratories
Chemistry · 33d
Cleared Dec 06, 1988
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY
K884687 · CGJ
Ciba Corning Diagnostics Corp.
Chemistry · 28d
Cleared Dec 05, 1988
IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40
K883148 · DHA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 132d
Cleared Dec 02, 1988
DELFIA TRIIODOTHYRONINE (T3) KIT
K883810 · CDP
Pharmacia, Inc.
Chemistry · 85d
Cleared Dec 02, 1988
MODIFICATION OF THE CEDIA DIGOXIN ASSAY
K884054 · KXT
Microgenics Corp.
Chemistry · 67d
Cleared Dec 02, 1988
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K884085 · JHY
Hybritech, Inc.
Chemistry · 66d
Cleared Dec 02, 1988
BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403
K884125 · JTC
Bio-Tek Instruments, Inc.
Chemistry · 63d
Cleared Dec 02, 1988
NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER
K884143 · CHL
Nova Biomedical Corp.
Chemistry · 63d
Cleared Dec 02, 1988
RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO
K884207 · DHA
Abbott Laboratories
Chemistry · 57d
Cleared Dec 02, 1988
MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85
K884436 · KSE
Harris Mfg. Co.
Chemistry · 42d
Cleared Dec 02, 1988
VISION LYTE (TM) POTASSIUM
K884566 · CEM
Abbott Laboratories
Chemistry · 31d
Cleared Nov 30, 1988
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745 · CGJ
Diagnostic Products Corp.
Chemistry · 90d
Cleared Nov 29, 1988
TECHNICON ASSIST POTASSIUM
K883585 · CEJ
Technicon Instruments Corp.
Chemistry · 98d
Cleared Nov 29, 1988
TECHNICON RA-100 SYSTEM POTASSIUM
K883586 · CEJ
Technicon Instruments Corp.
Chemistry · 98d
Cleared Nov 29, 1988
HOME CLINIC PREGNANCY TEST
K883826 · LCX
Vanguard Biomedical Corp.
Chemistry · 81d
Cleared Nov 29, 1988
DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD
K883890 · DIH
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 76d
Cleared Nov 29, 1988
DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER
K883891 · LAS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 76d
Cleared Nov 29, 1988
ROCHE REAGENT FOR INORGANIC PHOSPHORUS
K883962 · CEO
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Nov 29, 1988
ABBOTT IMX LH
K884138 · CEP
Abbott Laboratories
Chemistry · 60d
Cleared Nov 29, 1988
ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.
K884168 · JIS
The DU Pont Co.
Chemistry · 56d
Cleared Nov 29, 1988
TECHNICON ASSIST(R) CALCIUM METHOD
K884433 · CIC
Technicon Instruments Corp.
Chemistry · 39d
Cleared Nov 29, 1988
BIOTROL BILIRUBIN MONOREACTIF
K884480 · CIC
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Nov 16, 1988
AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)
K884105 · CHP
Amersham Corp.
Chemistry · 48d