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FDA 510(k)

ECA PREP

K-Number: K781117 · 1978-08-10

ApplicantElectrophoresis Corp. of America
Decision Date1978-08-10
Product CodeCEF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ECA PREP is the device name listed in this FDA 510(k) record. The listed applicant is Electrophoresis Corp. of America. It received FDA 510(k) clearance on 1978-08-10 under 510(k) number K781117. The device is classified under product code CEF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECA PREP?

ECA PREP is a medical device that received FDA 510(k) clearance on 1978-08-10. The listed applicant is Electrophoresis Corp. of America. The 510(k) number is K781117.

When did ECA PREP receive FDA 510(k) clearance?

ECA PREP received FDA 510(k) clearance on 1978-08-10, under 510(k) number K781117.

Who is the listed applicant for ECA PREP?

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

What is the FDA product code for ECA PREP?

The FDA product code for ECA PREP is CEF.

Other records listing Electrophoresis Corp. of America 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.

K802396GENERAL PROCEDURE AGAROSE FILMK792548ALKALINE PHOSPHATASE MARKERK792553AGAROSE BARBITAL-EDTA BUFFERK792551ALKALINE PHOSPHATASE REAGENTK792547AGAROSE BARBITAL BUFFERK792574MOPSO BUFFER

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Related Devices (Code: CEF)

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.

K130500CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENTSebiaK972274SPIFEHelena LaboratoriesK973316REP SPE VIS-60/40 KITHelena LaboratoriesK963018BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESISBio-RadK964453REP 3 FLUR SPE-60 KITHelena LaboratoriesK960029HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KITMorax

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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