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)

HISTOFREEZER DEVICE

K-Number: K982358 · 1998-10-02

ApplicantOraSure Technologies, Inc.
Decision Date1998-10-02
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HISTOFREEZER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is OraSure Technologies, Inc.. It received FDA 510(k) clearance on 1998-10-02 under 510(k) number K982358. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISTOFREEZER DEVICE?

HISTOFREEZER DEVICE is a medical device that received FDA 510(k) clearance on 1998-10-02. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K982358.

When did HISTOFREEZER DEVICE receive FDA 510(k) clearance?

HISTOFREEZER DEVICE received FDA 510(k) clearance on 1998-10-02, under 510(k) number K982358.

Who is the listed applicant for HISTOFREEZER DEVICE?

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

What is the FDA product code for HISTOFREEZER DEVICE?

The FDA product code for HISTOFREEZER DEVICE is GEH.

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 OraSure Technologies, 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.

K060859COMPOUND W FREEZE OFF WART REMOVAL SYSTEMK023487HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAMEK013882OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110IK020371UPLINK TEST SYSTEMK011057INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXXK002375STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I

View all 29 devices →

Related Devices (Code: GEH)

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.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

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.

↑