BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B

Microtools, Assisted Reproduction (pipettes)

HUMAGEN FERTILITY DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Humagen Fertility Diagnostics, Inc. with the FDA for Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-mbb,10-mbb-b,10-mpb,10-mpb-b.

Pre-market Notification Details

• Device ID: K012811
• 510k Number: K012811
• Device Name: BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B
• Classification: Microtools, Assisted Reproduction (pipettes)
• Applicant: HUMAGEN FERTILITY DIAGNOSTICS, INC. 2400 HUNTER'S WAY Charlottesville, VA 22911
• Contact: Cindy Showalter
• Correspondent: Cindy Showalter; HUMAGEN FERTILITY DIAGNOSTICS, INC. 2400 HUNTER'S WAY Charlottesville, VA 22911
• Product Code: MQH
• CFR Regulation Number: 884.6130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-08-22
• Decision Date: 2002-02-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20888937013560	K012811	000
20888937900884	K012811	000
20888937900921	K012811	000
20888937900938	K012811	000
20888937900945	K012811	000
20888937900969	K012811	000
20888937900983	K012811	000
20888937900990	K012811	000
20888937901003	K012811	000
20888937901010	K012811	000
20888937901034	K012811	000
20888937901041	K012811	000
20888937901065	K012811	000
20888937901089	K012811	000
20888937901119	K012811	000
20888937901140	K012811	000
20888937900853	K012811	000
20888937900846	K012811	000
20888937013577	K012811	000
20888937013584	K012811	000
20888937013591	K012811	000
20888937013607	K012811	000
20888937013614	K012811	000
20888937019791	K012811	000
20888937900556	K012811	000
20888937900600	K012811	000
20888937900624	K012811	000
20888937900662	K012811	000
20888937900693	K012811	000
20888937900709	K012811	000
20888937900723	K012811	000
20888937900747	K012811	000
20888937900839	K012811	000
20888937901157	K012811	000
20888937901188	K012811	000
20888937901652	K012811	000
20888937901669	K012811	000
20888937904097	K012811	000
20888937904127	K012811	000
20888937904219	K012811	000
20888937904240	K012811	000
20888937904271	K012811	000
20888937904318	K012811	000
20888937904325	K012811	000
20888937904349	K012811	000
20888937904356	K012811	000
20888937904394	K012811	000
20888937904417	K012811	000
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20888937911569	K012811	000
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20888937901591	K012811	000
20888937901201	K012811	000
20888937901249	K012811	000
20888937901294	K012811	000
20888937901324	K012811	000
20888937901331	K012811	000
20888937901355	K012811	000
20888937901379	K012811	000
20888937901423	K012811	000
20888937901447	K012811	000
20888937901454	K012811	000
20888937901485	K012811	000
20888937901515	K012811	000
20888937901546	K012811	000
20888937901560	K012811	000
20888937901584	K012811	000
20888937911576	K012811	000