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
8569–8592 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 13, 1987
DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)
K864863 · JKA
Dynatech Laboratories, Inc.
Chemistry · 33d
Cleared Jan 13, 1987
ALKALINE PHOSPHATASE
K864905 · CJE
Tech-Co, Inc.
Chemistry · 29d
Cleared Jan 12, 1987
OHMEDA 6000 MULTI-GAS MONITOR
K863959 · JJQ
Ohmeda Medical
Chemistry · 94d
Cleared Jan 09, 1987
TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS
K861202 · JJY
Nms Pharmaceuticals, Inc.
Chemistry · 284d
Cleared Jan 09, 1987
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
K863999 · LCX
Leeco Diagnostics, Inc.
Chemistry · 87d
Cleared Jan 09, 1987
SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY)
K864267 · DPM
Millipore Corp.
Chemistry · 72d
Cleared Jan 09, 1987
TERUMO OVATION SPECTROPHOTOMETER
K864285 · JJQ
Terumo Medical Corp.
Chemistry · 71d
Cleared Jan 09, 1987
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
K864373 · LCX
Unipath , Ltd.
Chemistry · 65d
Cleared Jan 09, 1987
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K864741 · CIC
Tech-Co, Inc.
Chemistry · 36d
Cleared Jan 09, 1987
WAKO(TM) AUTOKIT GPT
K864850 · CKA
Wako Chemicals USA, Inc.
Chemistry · 30d
Cleared Jan 09, 1987
ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE
K864966 · CGF
Diagnostics Biochem Canada, Inc.
Chemistry · 18d
Cleared Jan 09, 1987
GENERAL PURPOSE CENTRIFUGE
K864974 · JQC
Norfolk Scientific, Inc.
Chemistry · 21d
Cleared Jan 07, 1987
TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP
K864677 · JLW
Serono Diagnostics, Inc.
Chemistry · 36d
Cleared Jan 06, 1987
CANWEST OVU-BLUE
K862055 · CEP
Canwest Medictex, Inc.
Chemistry · 221d
Cleared Jan 05, 1987
ABBOTT SPECTRUM GLUCOSE REAGENT
K864224 · CGA
Abbott Laboratories
Chemistry · 69d
Cleared Jan 05, 1987
RAICHEM(TM) AMMONIA REAGENT
K864706 · JIF
Reagents Applications, Inc.
Chemistry · 34d
Cleared Jan 05, 1987
TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY
K864945 · JFH
Hybritech, Inc.
Chemistry · 19d
Cleared Dec 31, 1986
MAGNESIOMETER
K863069 · JGJ
J. D. Assoc.
Chemistry · 141d
Cleared Dec 31, 1986
SYNCHRON CX3
K864236 · JJF
Beckman Instruments, Inc.
Chemistry · 64d
Cleared Dec 31, 1986
QKO (TM) AMYLASE B-HA
K864303 · JFJ
Wako Chemicals USA, Inc.
Chemistry · 61d
Cleared Dec 31, 1986
AP1 COLORIMETER
K864634 · JJQ
Awareness Technology, Inc.
Chemistry · 36d
Cleared Dec 31, 1986
CHLORIDE REAGENT
K864713 · CHJ
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 31, 1986
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Dec 31, 1986
ALANINE AMINO TRANSFERASE ALT/SGPT
K864906 · CKA
Tech-Co, Inc.
Chemistry · 16d