Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

37 results for "Diagnostic Hybrids, Inc."
1–24 of 37
Search insights Median review: 81d Cleared: 97% Top manufacturer: Diagnostic Hybrids, Inc. Lead specialty: Microbiology
Not Cleared May 13, 2014
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
DEN140004 · PGI
Diagnostic Hybrids, Inc.
Microbiology · 81d
Cleared May 18, 2010
THYRETAIN TM TSI REPORTER BIOASSAY
K092229 · JZO
Diagnostic Hybrids, Inc.
Immunology · 299d
Cleared Dec 23, 2009
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
K093415 · GQS
Diagnostic Hybrids, Inc.
Microbiology · 51d
Cleared Dec 04, 2009
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
K093233 · OMG
Diagnostic Hybrids, Inc.
Microbiology · 51d
Cleared Oct 21, 2009
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
K092882 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 33d
Cleared Sep 11, 2009
D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
K091171 · OMG
Diagnostic Hybrids, Inc.
Microbiology · 142d
Cleared Aug 28, 2009
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K092300 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 30d
Cleared Aug 28, 2009
ELVIS HSV ID AND D3 TYPING TEST SYSTEM
K091753 · GQL
Diagnostic Hybrids, Inc.
Microbiology · 73d
Cleared May 21, 2009
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K083391 · JZO
Diagnostic Hybrids, Inc.
Immunology · 185d
Cleared Mar 06, 2009
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
K090073 · OMG
Diagnostic Hybrids, Inc.
Microbiology · 53d
Cleared Dec 23, 2008
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
K081928 · LKT
Diagnostic Hybrids, Inc.
Microbiology · 169d
Cleared Dec 23, 2008
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
K081746 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 187d
Cleared Jun 13, 2008
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
K081164 · LIN
Diagnostic Hybrids, Inc.
Microbiology · 50d
Cleared Oct 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING...
K070265 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 268d
Cleared Sep 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
K063675 · LJP
Diagnostic Hybrids, Inc.
Microbiology · 287d
Cleared Sep 21, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL...
K063798 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 273d
Cleared Aug 30, 2007
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
K070206 · GQW
Diagnostic Hybrids, Inc.
Microbiology · 220d
Cleared Nov 20, 2006
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K061101 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 214d
Cleared Dec 18, 2002
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 126d
Cleared Nov 18, 1997
ELVIS HSV ID/TYPING TEST SYSTEM
K971662 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 203d
Cleared Sep 25, 1997
FRESH CELLS HFF
K973214 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
FRESH CELLS LLC-MK2
K973213 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
FRESH CELLS WI-38
K973212 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
FRESH CELLS MV1LU
K973211 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d