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FDA 510(k)

HYALURONIDASE, 80 U/ML

K-Number: K991393 · 2000-02-02

ApplicantSage Biopharma
Decision Date2000-02-02
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYALURONIDASE, 80 U/ML is the device name listed in this FDA 510(k) record. The listed applicant is Sage Biopharma. It received FDA 510(k) clearance on 2000-02-02 under 510(k) number K991393. 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 HYALURONIDASE, 80 U/ML?

HYALURONIDASE, 80 U/ML is a medical device that received FDA 510(k) clearance on 2000-02-02. The listed applicant is Sage Biopharma. The 510(k) number is K991393.

When did HYALURONIDASE, 80 U/ML receive FDA 510(k) clearance?

HYALURONIDASE, 80 U/ML received FDA 510(k) clearance on 2000-02-02, under 510(k) number K991393.

Who is the listed applicant for HYALURONIDASE, 80 U/ML?

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

What is the FDA product code for HYALURONIDASE, 80 U/ML?

The FDA product code for HYALURONIDASE, 80 U/ML is MQL.

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Other records listing Sage Biopharma 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.

K003734SERUM PROTEIN SUBSTITUTEK002836MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTUREK991396WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 LK9913901.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDIK991378PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED

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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