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FDA 510(k)

I.E.C COLUMN

K-Number: K830918 · 1983-04-27

ApplicantBerwick Medical Products, Inc.
Decision Date1983-04-27
Product CodeKEA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I.E.C COLUMN is the device name listed in this FDA 510(k) record. The listed applicant is Berwick Medical Products, Inc.. It received FDA 510(k) clearance on 1983-04-27 under 510(k) number K830918. The device is classified under product code KEA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.E.C COLUMN?

I.E.C COLUMN is a medical device that received FDA 510(k) clearance on 1983-04-27. The listed applicant is Berwick Medical Products, Inc.. The 510(k) number is K830918.

When did I.E.C COLUMN receive FDA 510(k) clearance?

I.E.C COLUMN received FDA 510(k) clearance on 1983-04-27, under 510(k) number K830918.

Who is the listed applicant for I.E.C COLUMN?

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

What is the FDA product code for I.E.C COLUMN?

The FDA product code for I.E.C COLUMN is KEA.

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 Berwick Medical Products, 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.

K850800DROPSTIRS - PLASTIC DISPOSABLE PIPETK842018ISO-SEP SYSTEMK831434ISO-SEP SYSTEMK831289PREFILLED IEC COLUMNS

Related Devices (Code: KEA)

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.

K890997ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)Atlantic Wholesale, Inc.K844948SYVA SOLID PHASE COLUMNSSyva Co.K842028CM-TRISACRYL M DEAE-TRISACRYL MLkb Instruments, Inc.K833320AMBERLITE CG50 RESIN, 100-200 MESHBiosan Laboratories, Inc.K833319BIO-REX 70 RESIN 100-200 MESH PH6.2Biosan Laboratories, Inc.K831027EXTRELUT QE EXTRACTION COLUMNSEmd Chemicals, 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.

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