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)

CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO

K-Number: K930208 · 1993-04-20

ApplicantHeraeus Kulzer, Inc.
Decision Date1993-04-20
Product CodeDLI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1993-04-20 under 510(k) number K930208. The device is classified under product code DLI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO?

CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO is a medical device that received FDA 510(k) clearance on 1993-04-20. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K930208.

When did CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO receive FDA 510(k) clearance?

CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO received FDA 510(k) clearance on 1993-04-20, under 510(k) number K930208.

Who is the listed applicant for CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO?

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

What is the FDA product code for CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO?

The FDA product code for CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO is DLI.

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 Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

View all 145 devices →

Related Devices (Code: DLI)

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.

K950180DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHODE.I. Dupont DE Nemours & Co., Inc.K860350SERUM CHOLINESTERASE REAGENT SETSterling Diagnostics, Inc.K860641EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93Em Diagnostic Systems, Inc.K833062SERUM CHOLINESTERASE REAGENT SETSterling Biochemical, Inc.K771024CHOLINESTERASE REAGENT SYSTEMAmerican Monitor Corp.

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.

↑