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FDA 510(k)

PREFILLED IEC COLUMNS

K-Number: K831289 · 1983-06-16

ApplicantBerwick Medical Products, Inc.
Decision Date1983-06-16
Product CodeDJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREFILLED IEC COLUMNS 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 1983-06-16 under 510(k) number K831289. The device is classified under product code DJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREFILLED IEC COLUMNS?

PREFILLED IEC COLUMNS is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Berwick Medical Products, Inc.. The 510(k) number is K831289.

When did PREFILLED IEC COLUMNS receive FDA 510(k) clearance?

PREFILLED IEC COLUMNS received FDA 510(k) clearance on 1983-06-16, under 510(k) number K831289.

Who is the listed applicant for PREFILLED IEC COLUMNS?

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 PREFILLED IEC COLUMNS?

The FDA product code for PREFILLED IEC COLUMNS is DJY.

Related Clinical Trials

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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 SYSTEMK830918I.E.C COLUMN

Related Devices (Code: DJY)

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.

K890113THE CDI(R) SYSTEM 400Cardiovascular Devices, Inc.K883615LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73Supelco, Inc.K881361SOLID PHASE EXTRACTION TUBESSupelco, Inc.K850963DUPONT PREP TYPE SI EXTRACITON CARTRIDGEE.I. Dupont DE Nemours & Co., Inc.K840985TRISACRYL GF 05 & TRISACRYL GF 2000Lkb Instruments, Inc.K832198HC40/HC75 PREPACKED COLUMSHamilton Co.

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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