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)

BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY

K-Number: K952839 · 1995-08-24

ApplicantBoehringer Mannheim Corp.
Decision Date1995-08-24
Product CodeDML
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BOEHRINGER MANNHEIM ETHYL ALCOHOL 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 1995-08-24 under 510(k) number K952839. The device is classified under product code DML. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY?

BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K952839.

When did BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY receive FDA 510(k) clearance?

BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY received FDA 510(k) clearance on 1995-08-24, under 510(k) number K952839.

Who is the listed applicant for BOEHRINGER MANNHEIM ETHYL ALCOHOL 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 BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY?

The FDA product code for BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY is DML.

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: DML)

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.

K013538ETHANOLAbbott LaboratoriesK993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409ULSyva Co.K963197ON.SITE ALCOHOLAnsys, Inc.K953765AXSYM REA ETHANOLAbbott LaboratoriesK923337ON*SITE ALCOHOLToxi-Lab, Inc.K914777SIGMA PROCEDURE NO. 333-UVSigma 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.

↑