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FDA 510(k)

HYDRAGEL 6 CSF KIT

K-Number: K981048 · 1998-10-07

ApplicantMorax
Decision Date1998-10-07
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HYDRAGEL 6 CSF KIT is the device name listed in this FDA 510(k) record. The listed applicant is Morax. It received FDA 510(k) clearance on 1998-10-07 under 510(k) number K981048. The device is classified under product code CFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRAGEL 6 CSF KIT?

HYDRAGEL 6 CSF KIT is a medical device that received FDA 510(k) clearance on 1998-10-07. The listed applicant is Morax. The 510(k) number is K981048.

When did HYDRAGEL 6 CSF KIT receive FDA 510(k) clearance?

HYDRAGEL 6 CSF KIT received FDA 510(k) clearance on 1998-10-07, under 510(k) number K981048.

Who is the listed applicant for HYDRAGEL 6 CSF 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 6 CSF KIT?

The FDA product code for HYDRAGEL 6 CSF KIT is CFF.

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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: CFF)

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.

K203184HYDRASHIFT 2/4 isatuximabSebiaK192095CAPI 3 Immunotyping, Capillarys 3 TeraSebiaK190851HYDRASHIFT 2/4 daratumumabSebiaK172195HYDRASHIFT 2/4 daratumumab, daratumumab ControlSebiaK161928CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROLSebiaK120169INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENTGrifols USA, LLC

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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