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FDA 510(k)

SERUM PROTEIN SUBSTITUTE

K-Number: K003734 · 2000-12-21

ApplicantSage Biopharma
Decision Date2000-12-21
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SERUM PROTEIN SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Sage Biopharma. It received FDA 510(k) clearance on 2000-12-21 under 510(k) number K003734. 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 SERUM PROTEIN SUBSTITUTE?

SERUM PROTEIN SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2000-12-21. The listed applicant is Sage Biopharma. The 510(k) number is K003734.

When did SERUM PROTEIN SUBSTITUTE receive FDA 510(k) clearance?

SERUM PROTEIN SUBSTITUTE received FDA 510(k) clearance on 2000-12-21, under 510(k) number K003734.

Who is the listed applicant for SERUM PROTEIN SUBSTITUTE?

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 SERUM PROTEIN SUBSTITUTE?

The FDA product code for SERUM PROTEIN SUBSTITUTE 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.

K002836MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTUREK991396WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 LK991393HYALURONIDASE, 80 U/MLK9913901.5 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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