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FDA 510(k)

ECA (SPECIAL) HEME BUFFER

K-Number: K791008 · 1979-08-03

ApplicantElectrophoresis Corp. of America
Decision Date1979-08-03
Product CodeJBD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ECA (SPECIAL) 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 1979-08-03 under 510(k) number K791008. 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 (SPECIAL) HEME BUFFER?

ECA (SPECIAL) HEME BUFFER is a medical device that received FDA 510(k) clearance on 1979-08-03. The listed applicant is Electrophoresis Corp. of America. The 510(k) number is K791008.

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

ECA (SPECIAL) HEME BUFFER received FDA 510(k) clearance on 1979-08-03, under 510(k) number K791008.

Who is the listed applicant for ECA (SPECIAL) 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 (SPECIAL) HEME BUFFER?

The FDA product code for ECA (SPECIAL) HEME BUFFER is JBD.

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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: JBD)

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.

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 LaboratoriesK991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)MoraxK982426SPIFE ALKALINE HEMOGLOBINHelena LaboratoriesK931503REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)Helena Laboratories

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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