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)

NORMAL SALINE STERILE

K-Number: K864249 · 1987-03-31

ApplicantMds Laboratories, Inc.
Decision Date1987-03-31
Product CodeLIB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NORMAL SALINE STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Mds Laboratories, Inc.. It received FDA 510(k) clearance on 1987-03-31 under 510(k) number K864249. The device is classified under product code LIB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMAL SALINE STERILE?

NORMAL SALINE STERILE is a medical device that received FDA 510(k) clearance on 1987-03-31. The listed applicant is Mds Laboratories, Inc.. The 510(k) number is K864249.

When did NORMAL SALINE STERILE receive FDA 510(k) clearance?

NORMAL SALINE STERILE received FDA 510(k) clearance on 1987-03-31, under 510(k) number K864249.

Who is the listed applicant for NORMAL SALINE STERILE?

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

What is the FDA product code for NORMAL SALINE STERILE?

The FDA product code for NORMAL SALINE STERILE is LIB.

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 Mds Laboratories, 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.

K864241DNASE AGARK864242HEKTOEN ENTERIC AGARK864252THAYER-MARTIN JEMBECK864247MUELLER HINTON AGAR WITH 5% SHEEP BLOODK864244GARNERELLA VAGINALIS IDENTIFICATION KITK864243MACCONKEY AGAR

View all 21 devices →

Related Devices (Code: LIB)

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.

K023677OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)OsmetechK920416SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMBBehring Diagnostics, Inc.K912558GULL ELISAWAREGull Laboratories, Inc.K872273CORNING EASY WASH ELISA PLATESCorning Medical & ScientificK871559CELL LIFTERCorning Costar Corp.K863789CORNING ELISA PLATESCorning Medical & Scientific

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.

↑