FDA 510(k)

ECA HEME BUFFER

K-Number: K781119 · 1978-08-14

ApplicantElectrophoresis Corp. of America

Decision Date1978-08-14

Product CodeJBD

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ECA HEME BUFFER 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 1978-08-14 under 510(k) number K781119. The device is classified under product code JBD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECA HEME BUFFER?

ECA HEME BUFFER is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Electrophoresis Corp. of America. The 510(k) number is K781119.

When did ECA HEME BUFFER receive FDA 510(k) clearance?

ECA HEME BUFFER received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781119.

Who is the listed applicant for ECA HEME BUFFER?

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 HEME BUFFER?

The FDA product code for ECA HEME BUFFER is JBD.

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Other records listing Electrophoresis Corp. of America as applicant

K802396GENERAL PROCEDURE AGAROSE FILM K792548ALKALINE PHOSPHATASE MARKER K792553AGAROSE BARBITAL-EDTA BUFFER K792551ALKALINE PHOSPHATASE REAGENT K792547AGAROSE BARBITAL BUFFER K792574MOPSO BUFFER

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Related Devices (Code: JBD)

K053571MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMInterlab S.R.L.K032862INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMInterlab S.R.L.K992199ACID HEMOGLOBIN KITHelena Laboratories K991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)Morax K982426SPIFE ALKALINE HEMOGLOBINHelena Laboratories K931503REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)Helena Laboratories

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.