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)

LOWENSTEIN-JENSEN, W/NACL

K-Number: K880124 · 1988-03-31

ApplicantHardy Media
Decision Date1988-03-31
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LOWENSTEIN-JENSEN, W/NACL is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Media. It received FDA 510(k) clearance on 1988-03-31 under 510(k) number K880124. The device is classified under product code JSJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOWENSTEIN-JENSEN, W/NACL?

LOWENSTEIN-JENSEN, W/NACL is a medical device that received FDA 510(k) clearance on 1988-03-31. The listed applicant is Hardy Media. The 510(k) number is K880124.

When did LOWENSTEIN-JENSEN, W/NACL receive FDA 510(k) clearance?

LOWENSTEIN-JENSEN, W/NACL received FDA 510(k) clearance on 1988-03-31, under 510(k) number K880124.

Who is the listed applicant for LOWENSTEIN-JENSEN, W/NACL?

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

What is the FDA product code for LOWENSTEIN-JENSEN, W/NACL?

The FDA product code for LOWENSTEIN-JENSEN, W/NACL is JSJ.

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 Hardy Media 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.

K880134MIDDLEBROOK 7H11 AGARK880122MIDDLEBROOK 7H9 BROTHK880131LOWENSTEIN-JENSEN, GRUFTK880133MIL MEDIUMK880126LAURYL TRYPTOSE BROTHK880116MRVP BROTH

View all 114 devices →

Related Devices (Code: JSJ)

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.

K882463POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421Lakewood Biochemical Co., Inc.K881544LITTMAN AGARAcumedia Manufacturers, Inc.K881561TERGITOL 7 BROTHAcumedia Manufacturers, Inc.K881526CHAPMAN STONE MEDIUMAcumedia Manufacturers, Inc.K881571YM BROTHAcumedia Manufacturers, Inc.K881578STREPTOSELAcumedia Manufacturers, 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.

↑