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FDA 510(k)

HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT

K-Number: K972591 · 1998-03-04

ApplicantMorax
Decision Date1998-03-04
Product CodeJKM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT is the device name listed in this FDA 510(k) record. The listed applicant is Morax. It received FDA 510(k) clearance on 1998-03-04 under 510(k) number K972591. The device is classified under product code JKM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT?

HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT is a medical device that received FDA 510(k) clearance on 1998-03-04. The listed applicant is Morax. The 510(k) number is K972591.

When did HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT receive FDA 510(k) clearance?

HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT received FDA 510(k) clearance on 1998-03-04, under 510(k) number K972591.

Who is the listed applicant for HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT?

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

What is the FDA product code for HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT?

The FDA product code for HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT is JKM.

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Other records listing Morax 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.

K033277HYDRAGEL CSF ISOFOCUSING KITSK012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123K992148HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KITK991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)K990250HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0K981048HYDRAGEL 6 CSF KIT

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Related Devices (Code: JKM)

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K080916CAPILLARYS URINESebiaK070486CAPILLARYS URINE (PN 2012)Sebia, Inc.K050119PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KITBeckman Coulter, Inc.

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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