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
6937–6960 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 12, 1990
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
K900718 · LCP
Roche Diagnostic Systems, Inc.
Chemistry · 118d
Cleared Jun 12, 1990
REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)
K901463 · JQJ
Helena Laboratories
Chemistry · 76d
Cleared Jun 12, 1990
PROLACTIN (LACTOGEN) TEST SYSTEM
K901673 · CFT
Baxter Healthcare Corp
Chemistry · 63d
Cleared Jun 12, 1990
MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
K901858 · CET
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 49d
Cleared Jun 12, 1990
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS
K902095 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 35d
Cleared Jun 12, 1990
HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)
K902155 · JIM
Hichem Diagnostics
Chemistry · 28d
Cleared Jun 12, 1990
COULTER SERUM IRON/UIBC REAGENT
K902173 · JIY
Coulter Corp.
Chemistry · 29d
Cleared Jun 12, 1990
COULTER UREA NITROGEN REAGENT
K902175 · CDQ
Coulter Corp.
Chemistry · 29d
Cleared Jun 12, 1990
COULTER DIRECT BILIRUBIN
K902199 · CIG
Coulter Corp.
Chemistry · 27d
Cleared Jun 12, 1990
COULTER CARBON DIOXIDE REAGENT
K902229 · KHS
Coulter Corp.
Chemistry · 26d
Cleared Jun 12, 1990
BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS
K902267 · CHL
Phoenix Diagnostics, Inc.
Chemistry · 22d
Cleared Jun 06, 1990
BLOOD GAS CONTROLS
K901985 · JJS
Phoenix Diagnostics, Inc.
Chemistry · 35d
Cleared Jun 06, 1990
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406
K902123 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Jun 06, 1990
ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)
K902266 · JJR
Phoenix Diagnostics, Inc.
Chemistry · 16d
Cleared May 31, 1990
NEOCOAT T4
K901939 · CDX
Neometrics, Inc.
Chemistry · 31d
Cleared May 31, 1990
IRON REAGENTS PRODUCT CODES 7725 AND 7726
K901960 · JMO
American Research Products Co.
Chemistry · 30d
Cleared May 31, 1990
PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463
K901964 · CEO
American Research Products Co.
Chemistry · 30d
Cleared May 31, 1990
BLOOD GAS/CO-OXIMETRY CONTROL
K901976 · JJS
Phoenix Diagnostics, Inc.
Chemistry · 29d
Cleared May 31, 1990
CO-OXIMETER CONTROLS
K901986 · JJS
Phoenix Diagnostics, Inc.
Chemistry · 29d
Cleared May 31, 1990
DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET
K901988 · JJY
Casco Standards
Chemistry · 29d
Cleared May 30, 1990
ROTAG CONTROLS
K900719 · JJX
Roche Diagnostic Systems, Inc.
Chemistry · 105d
Cleared May 30, 1990
COULTER ALBUMIN REAGENT
K901268 · CIX
Coulter Corp.
Chemistry · 75d
Cleared May 24, 1990
DSL C-PEPTIDE RIA (DSL #7000)
K896420 · JKD
Diagnostic Systems Laboratories, Inc.
Chemistry · 197d
Cleared May 24, 1990
NIIC MODEL: DX901 ASPIRATION SYSTEM
K900185 · JFL
Niic U.S.A., Inc.
Chemistry · 128d