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)

HISTO-CENTER II

K-Number: K792095 · 1979-11-20

ApplicantThermolyne Corp.
Decision Date1979-11-20
Product CodeIDW
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

HISTO-CENTER II is the device name listed in this FDA 510(k) record. The listed applicant is Thermolyne Corp.. It received FDA 510(k) clearance on 1979-11-20 under 510(k) number K792095. The device is classified under product code IDW. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTO-CENTER II?

HISTO-CENTER II is a medical device that received FDA 510(k) clearance on 1979-11-20. The listed applicant is Thermolyne Corp.. The 510(k) number is K792095.

When did HISTO-CENTER II receive FDA 510(k) clearance?

HISTO-CENTER II received FDA 510(k) clearance on 1979-11-20, under 510(k) number K792095.

Who is the listed applicant for HISTO-CENTER II?

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

What is the FDA product code for HISTO-CENTER II?

The FDA product code for HISTO-CENTER II is IDW.

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 Thermolyne 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.

K771617SPECI-MIXK770914INCUBATOR, PORTABLE, ACT-STATK760928BLOOD BANK DRI-BATH

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.

↑