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)

CYTOLOGY FIXATIVE

K-Number: K770592 · 1977-05-20

ApplicantSurgipath Medical Industries, Inc.
Decision Date1977-05-20
Product CodeLEA
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

CYTOLOGY FIXATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Surgipath Medical Industries, Inc.. It received FDA 510(k) clearance on 1977-05-20 under 510(k) number K770592. The device is classified under product code LEA. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOLOGY FIXATIVE?

CYTOLOGY FIXATIVE is a medical device that received FDA 510(k) clearance on 1977-05-20. The listed applicant is Surgipath Medical Industries, Inc.. The 510(k) number is K770592.

When did CYTOLOGY FIXATIVE receive FDA 510(k) clearance?

CYTOLOGY FIXATIVE received FDA 510(k) clearance on 1977-05-20, under 510(k) number K770592.

Who is the listed applicant for CYTOLOGY FIXATIVE?

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

What is the FDA product code for CYTOLOGY FIXATIVE?

The FDA product code for CYTOLOGY FIXATIVE is LEA.

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 Surgipath Medical Industries, 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.

K883217SCHIFF REAGENTK881921C-E BRUSHK881922CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVEK881659TISSUE SECTION ADHESIVEK863549REUSABLE/DISPOSABLE AUTOPSY KNIFE SETK863616KNIFE MAKER

View all 30 devices →

Related Devices (Code: LEA)

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.

K873594TIF FECAL TESTDevetec, Inc.K761000PAP-TRAY I (CATALOG #C600-1)Lerner Laboratories, Inc.K761001PAP-TRAY II (CATALOG #C600-2)Lerner Laboratories, 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.

↑