Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

40 results for "Nova Biomedical Corporation"
1–24 of 40
Search insights Median review: 153d Cleared: 100% Top manufacturer: Nova Biomedical Corporation Lead specialty: Chemistry
Cleared Jan 21, 2026
Nova Max Creat eGFR Monitoring System
K251281 · SHB
Nova Biomedical Corporation
Chemistry · 272d
Cleared Jan 09, 2026
Nova Allegro UACR Assay, Nova Allegro Analyzer
K252206 · CGX
Nova Biomedical Corporation
Chemistry · 179d
Cleared Nov 22, 2024
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
K221326 · LCP
Nova Biomedical Corporation
Chemistry · 931d
Cleared Nov 19, 2024
Nova Allegro UACR Assay, Nova Allegro Analyzer
K221813 · CGX
Nova Biomedical Corporation
Chemistry · 881d
Cleared Feb 23, 2024
StatStrip Glucose Hospital Meter System
K232075 · PZI
Nova Biomedical Corporation
Chemistry · 226d
Cleared Sep 29, 2023
Stat Profile Prime Plus Analyzer System
K221900 · CHL
Nova Biomedical Corporation
Chemistry · 456d
Cleared Oct 18, 2022
Nova Primary Glucose Analyzer System
K203549 · CGA
Nova Biomedical Corporation
Chemistry · 683d
Cleared Apr 14, 2020
Stat Profile Prime Plus Analyzer System
K200403 · JGS
Nova Biomedical Corporation
Chemistry · 55d
Cleared Apr 06, 2020
Stat Profile Prime Plus Analyzer System
K200204 · GGZ
Nova Biomedical Corporation
Chemistry · 69d
Cleared Mar 13, 2020
Stat Profile Prime Plus Analyzer System
K200349 · CGA
Nova Biomedical Corporation
Chemistry · 30d
Cleared Jan 24, 2020
Stat Profile Prime Plus Analyzer System
K193246 · CHL
Nova Biomedical Corporation
Chemistry · 60d
Cleared Aug 16, 2019
Stat Profile Prime ES Comp Plus Analyzer System
K191626 · JFP
Nova Biomedical Corporation
Chemistry · 59d
Cleared Jul 19, 2019
Stat Profile Prime ES Comp Plus Analyzer System
K191365 · JGS
Nova Biomedical Corporation
Chemistry · 58d
Cleared Dec 13, 2018
StatStrip Xpress Glucose Hospital Meter System
K182552 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
StatStrip Xpress 2 Glucose Hospital Meter System
K182549 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Sep 26, 2018
Stat Profile Prime Plus Analyzer System
K180340 · CGA
Nova Biomedical Corporation
Chemistry · 231d
Cleared Aug 23, 2018
Stat Profile Prime Plus Analyzer System
K180186 · GGZ
Nova Biomedical Corporation
Chemistry · 212d
Cleared Aug 15, 2018
Stat Profile Prime Plus Analyzer System
K180428 · JGS
Nova Biomedical Corporation
Chemistry · 180d
Cleared Jul 17, 2018
Stat Profile Prime Plus Analyzer System
K173797 · CHL
Nova Biomedical Corporation
Chemistry · 215d
Cleared Jul 12, 2018
StatStrip Glucose Hospital Meter System
K181043 · PZI
Nova Biomedical Corporation
Chemistry · 84d
Cleared Nov 07, 2017
StatStrip Xpress Blood Glucose Monitoring System
K170464 · NBW
Nova Biomedical Corporation
Chemistry · 265d
Cleared May 26, 2017
Nova StatSensor Creatinine Hospital Meter System
K171059 · CGL
Nova Biomedical Corporation
Chemistry · 46d
Cleared Apr 11, 2017
Nova Max Uric Acid Monitoring System
K160990 · PTC
Nova Biomedical Corporation
Chemistry · 368d
Cleared Jan 06, 2017
StatStrip Xpress 2 Glucose Hospital Meter System
K163490 · PZI
Nova Biomedical Corporation
Chemistry · 25d