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
7369–7392 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 20, 1989
MINICLINIC OVULATION PREDICTION TEST
K891762 · CEP
Vanguard Biomedical Corp.
Chemistry · 118d
Cleared Jul 20, 1989
ACID PHOSPHATASE REAGENT
K892393 · CKB
Medical Analysis Systems, Inc.
Chemistry · 104d
Cleared Jul 20, 1989
CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE
K892500 · JGS
Ciba Corning Diagnostics Corp.
Chemistry · 98d
Cleared Jul 20, 1989
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS
K892668 · CIG
Catachem, Inc.
Chemistry · 98d
Cleared Jul 20, 1989
PANCREATIC A-AMYLASE PNP
K892848 · JFJ
Boehringer Mannheim Corp.
Chemistry · 93d
Cleared Jul 20, 1989
TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES
K892929 · CHJ
Technicon Instruments Corp.
Chemistry · 90d
Cleared Jul 20, 1989
REP(TM) CK-2 STAT KIT, CAT. NO. 3074
K893007 · CGS
Helena Laboratories
Chemistry · 87d
Cleared Jul 20, 1989
DOCUMENT(TM) URIC ACID LINEARITY TEST SET
K893139 · JIT
Casco Standards
Chemistry · 86d
Cleared Jul 20, 1989
BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME
K893269 · CGS
Beckman Instruments, Inc.
Chemistry · 79d
Cleared Jul 20, 1989
ALT REAGENT (PROCEDURE NUMBER 159)
K893560 · CKA
Sigma Chemical Co.
Chemistry · 72d
Cleared Jul 20, 1989
DADE LIPID-TROL
K893580 · JJY
Baxter Healthcare Corp
Chemistry · 72d
Cleared Jul 20, 1989
COBAS FARA CENTRIFUGAL ANALYZER
K893641 · JJG
Roche Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Jul 20, 1989
J&S IRON SATURATING REAGENTS
K893662 · JMO
J.S. Medical Assoc.
Chemistry · 66d
Cleared Jul 20, 1989
CENTRICON CONCENTRATOR
K893733 · JJH
Amicon, Inc.
Chemistry · 64d
Cleared Jul 20, 1989
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
K893752 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 62d
Cleared Jul 20, 1989
GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1
K893765 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 62d
Cleared Jun 23, 1989
DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET
K893140 · JJX
Casco Standards
Chemistry · 59d
Cleared Jun 23, 1989
DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET
K893141 · JJY
Casco Standards
Chemistry · 59d
Cleared Jun 23, 1989
DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET
K893142 · JJY
Casco Standards
Chemistry · 59d
Cleared Jun 23, 1989
SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION)
K893400 · JQW
Medical Robotics
Chemistry · 53d
Cleared Jun 23, 1989
URIC ACID REAGENT (PROCEDURE NUMBER 686)
K893416 · KNK
Sigma Chemical Co.
Chemistry · 52d
Cleared Jun 21, 1989
ACS COLLOID OSMOTIC PRESSURE CALIBRATOR
K892213 · JIW
Analytical Control Systems, Inc.
Chemistry · 79d
Cleared Jun 21, 1989
DELTA (TM) ROBOTIC PIPETTOR
K893031 · JQW
Diagnostic Products Corp.
Chemistry · 58d
Cleared Jun 21, 1989
BACTON TM, BASIC TM, APO A-I REAGENT
K893885 · DEL
Catachem, Inc.
Chemistry · 22d