Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2

K-Number: K120591 · 2012-04-17

ApplicantDiamond Diagnostics, Inc.
Decision Date2012-04-17
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-04-17 under 510(k) number K120591. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2?

DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 is a medical device that received FDA 510(k) clearance on 2012-04-17. The listed applicant is Diamond Diagnostics, Inc.. The 510(k) number is K120591.

When did DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 receive FDA 510(k) clearance?

DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 received FDA 510(k) clearance on 2012-04-17, under 510(k) number K120591.

Who is the listed applicant for DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2?

The FDA 510(k) record lists Diamond Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2?

The FDA product code for DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 is JIT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Diamond Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+K124009MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION CK121027DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGHK121040SMARTLYTE ELECTROLYTE ANALYZERK121140PROLYTE ELECTROLYTE ANALYZERK103364MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL

View all 25 devices →

Related Devices (Code: JIT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163521Lumipulse G LH CalibratorsFujirebio Diagnostics,Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑