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
7489–7512 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 20, 1989
DMA MICROPROTEIN PROCEDURE
K890868 · CEK
Data Medical Associates, Inc.
Chemistry · 27d
Cleared Mar 16, 1989
RECONDITIONED ASTRA (TM) 8
K883298 · JJF
Associated Electro-Medical Services,...
Chemistry · 224d
Cleared Mar 16, 1989
RECONDITIONED ASTRA(TM) 4
K883350 · JJF
Associated Electro-Medical Services,...
Chemistry · 219d
Cleared Mar 16, 1989
TSH MICROASSAY
K890579 · JLW
Diamedix Corp.
Chemistry · 38d
Cleared Mar 16, 1989
IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)
K890609 · CGS
Intl. Immunoassay Laboratories, Inc.
Chemistry · 37d
Cleared Mar 16, 1989
RIA-GNOST PROGESTERONE
K890836 · JLS
Cambridge Medical Technology
Chemistry · 23d
Cleared Mar 16, 1989
EIA READER MODEL EL301
K890854 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 23d
Cleared Mar 15, 1989
PG-NUMERIC(TM)
K883411 · JHF
Isolab, Inc.
Chemistry · 212d
Cleared Mar 15, 1989
RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)
K890414 · JJY
Amersham Corp.
Chemistry · 50d
Cleared Mar 15, 1989
RIATRAC PLUS
K890470 · JJY
Bd Becton Dickinson Vacutainer...
Chemistry · 43d
Cleared Mar 15, 1989
APEC GLUCOSE ANALYZER
K890524 · CGA
Amdev, Inc.
Chemistry · 41d
Cleared Mar 13, 1989
PROGENE MICROALBUMINURIA SCREEN
K882538 · JIR
Progene Corp.
Chemistry · 265d
Cleared Mar 13, 1989
LIPASE SR LIQUID STABLE REAGENT SET
K885078 · CET
Medical Analysis Systems, Inc.
Chemistry · 95d
Cleared Mar 13, 1989
IMPRES-MB REAGENT A AND REAGENT B
K890543 · JHX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 38d
Cleared Mar 13, 1989
HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2
K890583 · JIX
Hichem Diagnostics
Chemistry · 35d
Cleared Mar 10, 1989
CLINISTAT CHOLESTEROL REAGENT TEST
K884757 · CHH
Heraeus Kulzer, Inc.
Chemistry · 116d
Cleared Mar 10, 1989
HI CHEM WASH CONCENTRATE REAGENT #88805
K890578 · JQW
Hichem Diagnostics
Chemistry · 32d
Cleared Mar 09, 1989
TARGET(TM) QUANTITATIVE HCG
K890131 · JHI
V-Tech, Inc.
Chemistry · 56d
Cleared Mar 09, 1989
TOTAL PROTEIN REAGENT
K890278 · CEK
Sigma Chemical Co.
Chemistry · 50d
Cleared Mar 09, 1989
TRIGLYCERIDES - GPO REAGENT
K890337 · CDT
Alpkem Corp.
Chemistry · 45d
Cleared Mar 09, 1989
KENLOR HUMAN SPINAL FLUID CONTROL LIQUID
K890576 · JJY
Kenlor Industries, Inc.
Chemistry · 31d
Cleared Mar 09, 1989
KENLOR LIQUID URINE CONTROL
K890577 · JJW
Kenlor Industries, Inc.
Chemistry · 31d
Cleared Mar 08, 1989
DELFIA HLH SPEC KIT
K883814 · CEP
Pharmacia, Inc.
Chemistry · 181d
Cleared Mar 08, 1989
C&T PREGNANCY TEST KIT
K884489 · LCX
Healthcheck Corp.
Chemistry · 133d