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)

ELECSYS CEA ASSAY

K-Number: K964368 · 1997-06-16

ApplicantBoehringer Mannheim Corp.
Decision Date1997-06-16
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CEA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1997-06-16 under 510(k) number K964368. 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 ELECSYS CEA ASSAY?

ELECSYS CEA ASSAY is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K964368.

When did ELECSYS CEA ASSAY receive FDA 510(k) clearance?

ELECSYS CEA ASSAY received FDA 510(k) clearance on 1997-06-16, under 510(k) number K964368.

Who is the listed applicant for ELECSYS CEA ASSAY?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECSYS CEA ASSAY?

The FDA product code for ELECSYS CEA ASSAY 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 Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

View all 340 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.

↑