D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT

Antisera, Fluorescent, Human Metapneumovirus

DIAGNOSTIC HYBRIDS, INC.

The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for D3 Fastpoint L-dfa Rsv/mvp Identification Kit.

Pre-market Notification Details

• Device ID: K093233
• 510k Number: K093233
• Device Name: D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
• Classification: Antisera, Fluorescent, Human Metapneumovirus
• Applicant: DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701
• Contact: Ronald H Lollar
• Correspondent: Ronald H Lollar; DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701
• Product Code: OMG
• CFR Regulation Number: 866.3980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-14
• Decision Date: 2009-12-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30014613330837	K093233	000
30014613330820	K093233	000
30014613330813	K093233	000