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)

SECONDARY CALIBRATORS

K-Number: K904698 · 1990-11-28

ApplicantBionostics, Inc.
Decision Date1990-11-28
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SECONDARY CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 1990-11-28 under 510(k) number K904698. 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 SECONDARY CALIBRATORS?

SECONDARY CALIBRATORS is a medical device that received FDA 510(k) clearance on 1990-11-28. The listed applicant is Bionostics, Inc.. The 510(k) number is K904698.

When did SECONDARY CALIBRATORS receive FDA 510(k) clearance?

SECONDARY CALIBRATORS received FDA 510(k) clearance on 1990-11-28, under 510(k) number K904698.

Who is the listed applicant for SECONDARY CALIBRATORS?

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

What is the FDA product code for SECONDARY CALIBRATORS?

The FDA product code for SECONDARY CALIBRATORS 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 Bionostics, 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.

K131136GLUCOSE METER-CHECK SOLUTION FOR TAIDOCK123851GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEKK123966GLUCOSE METER-CHECK SOLUTION FOR BAYERK113764GLUCOSE METER-CHECK SOLUTION FOR INFOPIAK112352GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULTK112356GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE

View all 49 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.

↑