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FDA 510(k)

IDECAP DIALYZER

K-Number: K852764 · 1985-09-20

ApplicantTrans-National Trade Development Corp.
Decision Date1985-09-20
Product CodeFJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IDECAP DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Trans-National Trade Development Corp.. It received FDA 510(k) clearance on 1985-09-20 under 510(k) number K852764. The device is classified under product code FJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDECAP DIALYZER?

IDECAP DIALYZER is a medical device that received FDA 510(k) clearance on 1985-09-20. The listed applicant is Trans-National Trade Development Corp.. The 510(k) number is K852764.

When did IDECAP DIALYZER receive FDA 510(k) clearance?

IDECAP DIALYZER received FDA 510(k) clearance on 1985-09-20, under 510(k) number K852764.

Who is the listed applicant for IDECAP DIALYZER?

The FDA 510(k) record lists Trans-National Trade Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDECAP DIALYZER?

The FDA product code for IDECAP DIALYZER is FJH.

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.

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Other records listing Trans-National Trade Development 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.

K864451UV VISIBLE SPECTROPHOTOMETERS

Related Devices (Code: FJH)

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.

K920697DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMPNational Medical Care, Medical Products Div., Inc.K861646BIO-CARB D16000, D16001, AND D17000Societe D' Analyses Bio-Pharmaceutiques,Inc.K822395CF 1211 CAPILLARY FLOW DIALYZER CODETravenol Laboratories, S.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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