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)

STERILE EMPTY VIALS

K-Number: K875227 · 1988-03-04

ApplicantAllertech, Inc.
Decision Date1988-03-04
Product CodeLDH
DecisionSubstantially Equivalent

Device Summary

STERILE EMPTY VIALS is the device name listed in this FDA 510(k) record. The listed applicant is Allertech, Inc.. It received FDA 510(k) clearance on 1988-03-04 under 510(k) number K875227. The device is classified under product code LDH. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE EMPTY VIALS?

STERILE EMPTY VIALS is a medical device that received FDA 510(k) clearance on 1988-03-04. The listed applicant is Allertech, Inc.. The 510(k) number is K875227.

When did STERILE EMPTY VIALS receive FDA 510(k) clearance?

STERILE EMPTY VIALS received FDA 510(k) clearance on 1988-03-04, under 510(k) number K875227.

Who is the listed applicant for STERILE EMPTY VIALS?

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

What is the FDA product code for STERILE EMPTY VIALS?

The FDA product code for STERILE EMPTY VIALS is LDH.

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

Related Devices (Code: LDH)

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.

K950822SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIALSolopak Laboratories, Inc.K883686STERILE EMPTY GLASS VIALSFarris 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.

↑