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FDA 510(k)

LABILE REMOVING HEMOLYZING REAGENT

K-Number: K830804 · 1983-05-04

ApplicantCorning Medical & Scientific
Decision Date1983-05-04
Product CodeJBD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LABILE REMOVING HEMOLYZING REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Corning Medical & Scientific. It received FDA 510(k) clearance on 1983-05-04 under 510(k) number K830804. 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 LABILE REMOVING HEMOLYZING REAGENT?

LABILE REMOVING HEMOLYZING REAGENT is a medical device that received FDA 510(k) clearance on 1983-05-04. The listed applicant is Corning Medical & Scientific. The 510(k) number is K830804.

When did LABILE REMOVING HEMOLYZING REAGENT receive FDA 510(k) clearance?

LABILE REMOVING HEMOLYZING REAGENT received FDA 510(k) clearance on 1983-05-04, under 510(k) number K830804.

Who is the listed applicant for LABILE REMOVING HEMOLYZING REAGENT?

The FDA 510(k) record lists Corning Medical & Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABILE REMOVING HEMOLYZING REAGENT?

The FDA product code for LABILE REMOVING HEMOLYZING REAGENT is JBD.

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Other records listing Corning Medical & Scientific 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.

K875122DISPOSABLE STERILE SYRINGE FILTERSK872273CORNING EASY WASH ELISA PLATESK872076CORNING DISPOSABLE ROLLER BOTTLESK863789CORNING ELISA PLATESK854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYK853634CORNING CELL WELLS-MULTIPLE WELL PLATES

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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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