FDA 510(k)

PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA

K-Number: K991381 · 1999-09-24

Decision Date1999-09-24

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Andrology, Inc.. It received FDA 510(k) clearance on 1999-09-24 under 510(k) number K991381. 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 PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA?

PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Pacific Andrology, Inc.. The 510(k) number is K991381.

When did PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA receive FDA 510(k) clearance?

PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA received FDA 510(k) clearance on 1999-09-24, under 510(k) number K991381.

Who is the listed applicant for PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA?

The FDA 510(k) record lists Pacific Andrology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA?

The FDA product code for PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA is MQL.

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Other records listing Pacific Andrology, Inc. as applicant

K991388ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M

Related Devices (Code: MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato Corporation K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin 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.