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
5185–5208 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 10, 1995
NEONATAL BLOOD COLLECTION AND SCREENING FORM
K944618 · JKA
General Business Forms, Inc.
Chemistry · 232d
Cleared May 10, 1995
DSL ACTIVE IFGBP-3 ELISA
K951707 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 27d
Cleared May 10, 1995
ACTIVE IGF-I ELISA
K951752 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 23d
Cleared May 08, 1995
GLUCOSE (HK) REAGENT (PROCEDURE NO.16)
K945908 · CFR
Sigma Diagnostics, Inc.
Chemistry · 157d
Cleared May 08, 1995
OSTEOMARK(R)
K945946 · JMM
Ostex Intl., Inc.
Chemistry · 154d
Cleared May 08, 1995
DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE
K946354 · JMO
Data Medical Associates, Inc.
Chemistry · 129d
Cleared May 08, 1995
SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)
K950958 · JJE
Beckman Instruments, Inc.
Chemistry · 82d
Cleared May 08, 1995
AURAFLEX PROGESTERONE 150TEST PACK
K951630 · JLS
Organon Teknika Corp.
Chemistry · 31d
Cleared May 05, 1995
CIBA CORNING ACS CORTISOL IMMUNOASSAY
K945367 · CGR
Ciba Corning Diagnostics Corp.
Chemistry · 221d
Cleared May 05, 1995
VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER
K950432 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 92d
Cleared May 05, 1995
CAPITOL URINE DRUG SCREEN COLLECTION KIT
K951122 · KDW
Harry A. Schlakman
Chemistry · 67d
Cleared May 05, 1995
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
K951361 · LCP
Heraeus Kulzer, Inc.
Chemistry · 39d
Cleared May 02, 1995
WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS
K943978 · JJF
Waters Chromatography Division
Chemistry · 259d
Cleared May 02, 1995
HICHEM Y-GT REAGENT KIT
K946192 · JQB
Hichem Diagnostics
Chemistry · 133d
Cleared May 02, 1995
FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
K950292 · CGN
Miles, Inc.
Chemistry · 97d
Cleared May 02, 1995
CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY
K950921 · JLW
Nichols Institute Diagnostics
Chemistry · 62d
Cleared May 02, 1995
ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
K951360 · CHP
Bayer Corp.
Chemistry · 36d
Cleared May 02, 1995
AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL
K951435 · JJR
Aalto Scientific, Ltd.
Chemistry · 36d
Cleared May 02, 1995
AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK
K951638 · JHY
Organon Teknika Corp.
Chemistry · 22d
Cleared May 01, 1995
ACCUMETER HDL CHOLESTEROL TEST
K943279 · LBS
Chemtrak, Inc.
Chemistry · 298d
Cleared Apr 24, 1995
URINE REAGENT STRIPS-8 PARAMETERS
K943436 · JJB
Teco Diagnostics
Chemistry · 280d
Cleared Apr 21, 1995
COBAS CORE FREE T3 EIA
K942376 · CEC
Roche Diagnostic Systems, Inc.
Chemistry · 338d
Cleared Apr 20, 1995
ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM
K945271 · JJE
Bio-Chem Laboratory Systems, Inc.
Chemistry · 184d
Cleared Apr 20, 1995
TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
K950353 · JJE
Miles, Inc.
Chemistry · 80d