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FDA 510(k)

HYDRAGEL 15 HB A1C KIT

K-Number: K963844 · 1997-04-22

ApplicantMorax
Decision Date1997-04-22
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HYDRAGEL 15 HB A1C KIT is the device name listed in this FDA 510(k) record. The listed applicant is Morax. It received FDA 510(k) clearance on 1997-04-22 under 510(k) number K963844. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRAGEL 15 HB A1C KIT?

HYDRAGEL 15 HB A1C KIT is a medical device that received FDA 510(k) clearance on 1997-04-22. The listed applicant is Morax. The 510(k) number is K963844.

When did HYDRAGEL 15 HB A1C KIT receive FDA 510(k) clearance?

HYDRAGEL 15 HB A1C KIT received FDA 510(k) clearance on 1997-04-22, under 510(k) number K963844.

Who is the listed applicant for HYDRAGEL 15 HB A1C 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 15 HB A1C KIT?

The FDA product code for HYDRAGEL 15 HB A1C KIT is LCP.

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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 0K974854HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207

View all 12 devices →

Related Devices (Code: LCP)

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.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, 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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