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FDA 510(k)

ENHANCE HUMAN SERUM ALBUMIN

K-Number: K030850 · 2003-04-08

ApplicantConception Technologies
Decision Date2003-04-08
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENHANCE HUMAN SERUM ALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Conception Technologies. It received FDA 510(k) clearance on 2003-04-08 under 510(k) number K030850. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENHANCE HUMAN SERUM ALBUMIN?

ENHANCE HUMAN SERUM ALBUMIN is a medical device that received FDA 510(k) clearance on 2003-04-08. The listed applicant is Conception Technologies. The 510(k) number is K030850.

When did ENHANCE HUMAN SERUM ALBUMIN receive FDA 510(k) clearance?

ENHANCE HUMAN SERUM ALBUMIN received FDA 510(k) clearance on 2003-04-08, under 510(k) number K030850.

Who is the listed applicant for ENHANCE HUMAN SERUM ALBUMIN?

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

What is the FDA product code for ENHANCE HUMAN SERUM ALBUMIN?

The FDA product code for ENHANCE HUMAN SERUM ALBUMIN is MQL.

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Other records listing Conception Technologies 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.

K023717SPERM WASH MEDIUM WITH GENTAMICINK023655ENHANCE HTF MEDIUM WITH HEPESK020490PBS, PBSW WITH CATIONS AND PHENOL REDK01148110% PVP; 10% PVP IN EBSS SOLUTIONK011573HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUMK011462OIL FOR TISSUE CULTURE

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Related Devices (Code: MQL)

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.

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

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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