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FDA 510(k)

ISO-SEP SYSTEM

K-Number: K842018 · 1984-09-28

ApplicantBerwick Medical Products, Inc.
Decision Date1984-09-28
Product CodeCEX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISO-SEP SYSTEM 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 1984-09-28 under 510(k) number K842018. The device is classified under product code CEX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISO-SEP SYSTEM?

ISO-SEP SYSTEM is a medical device that received FDA 510(k) clearance on 1984-09-28. The listed applicant is Berwick Medical Products, Inc.. The 510(k) number is K842018.

When did ISO-SEP SYSTEM receive FDA 510(k) clearance?

ISO-SEP SYSTEM received FDA 510(k) clearance on 1984-09-28, under 510(k) number K842018.

Who is the listed applicant for ISO-SEP SYSTEM?

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 ISO-SEP SYSTEM?

The FDA product code for ISO-SEP SYSTEM is CEX.

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 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 PIPETK831434ISO-SEP SYSTEMK831289PREFILLED IEC COLUMNSK830918I.E.C COLUMN

Related Devices (Code: CEX)

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.

K872891LACTATE DEHYDROGENASE ISOENZYME 1Data Medical Associates, Inc.K851521LD-1(IMMUNO) SEPARATION SETSeragen Diagnostics, Inc.K821983TITAN GEL LDH ISOENZYME KITHelena LaboratoriesK821879ULTRACHEM T.P.Harleco DiagnosticsK800129CENTRIFICHEM CREATININEUnion Carbide Corp.K772356LDH ISOENZYME COLUMN REAGENT SETWorthington Biochemical Corp.

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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