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)

ASCORBIC ACID

K-Number: K842215 · 1984-08-02

ApplicantOrganon Teknika Corp.
Decision Date1984-08-02
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASCORBIC ACID is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1984-08-02 under 510(k) number K842215. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCORBIC ACID?

ASCORBIC ACID is a medical device that received FDA 510(k) clearance on 1984-08-02. The listed applicant is Organon Teknika Corp.. The 510(k) number is K842215.

When did ASCORBIC ACID receive FDA 510(k) clearance?

ASCORBIC ACID received FDA 510(k) clearance on 1984-08-02, under 510(k) number K842215.

Who is the listed applicant for ASCORBIC ACID?

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

What is the FDA product code for ASCORBIC ACID?

The FDA product code for ASCORBIC ACID is FIP.

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 Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

View all 130 devices →

Related Devices (Code: FIP)

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.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, 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.

↑