Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Diagnostic Hybrids, Inc. — Predicate Candidate Screening

37 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

81 daysmedian FDA review time
287 days90th percentile
37clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
DEN140004QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAYDiagnostic Hybrids, Inc.2014-05-13810
K092229THYRETAIN TM TSI REPORTER BIOASSAYDiagnostic Hybrids, Inc.2010-05-182990
K093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICADiagnostic Hybrids, Inc.2009-12-23510
K093233D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KITDiagnostic Hybrids, Inc.2009-12-04510
K092882D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATDiagnostic Hybrids, Inc.2009-10-21330
K091171D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.2009-09-111420
K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMDiagnostic Hybrids, Inc.2009-08-28730
K092300MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & IDiagnostic Hybrids, Inc.2009-08-28300
K083391THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAYDiagnostic Hybrids, Inc.2009-05-211850
K090073D3 DFA METAPNEUMOVIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.2009-03-06530
K081928D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.2008-12-231690
K081746D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.2008-12-231870
K081164D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATIODiagnostic Hybrids, Inc.2008-06-13500
K070265DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATIDiagnostic Hybrids, Inc.2007-10-242680
K063675DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KDiagnostic Hybrids, Inc.2007-09-242870
K063798DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATIDiagnostic Hybrids, Inc.2007-09-212730
K070206DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATDiagnostic Hybrids, Inc.2007-08-302200
K061101D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.2006-11-202140
K022713DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.2002-12-181260
K971662ELVIS HSV ID/TYPING TEST SYSTEMDiagnostic Hybrids, Inc.1997-11-182030
K973212FRESH CELLS WI-38Diagnostic Hybrids, Inc.1997-09-25290
K973211FRESH CELLS MV1LUDiagnostic Hybrids, Inc.1997-09-25290
K973210FRESH CELLS NCI H292Diagnostic Hybrids, Inc.1997-09-25290
K973209FRESH CELLS VERODiagnostic Hybrids, Inc.1997-09-25290
K973214FRESH CELLS HFFDiagnostic Hybrids, Inc.1997-09-25290
K973213FRESH CELLS LLC-MK2Diagnostic Hybrids, Inc.1997-09-25290
K972414FRESHCELLSDiagnostic Hybrids, Inc.1997-08-29630
K960578ELVIS HSV GOLDDiagnostic Hybrids, Inc.1996-09-052060
K962311FRESHFROZENCELLSDiagnostic Hybrids, Inc.1996-08-29730
K962782FRESHFROZEN CELLS, HEP-2Diagnostic Hybrids, Inc.1996-08-29430
K962780FRESHCELLS, HEP-2Diagnostic Hybrids, Inc.1996-08-29430
K962306FRESH CELLS MULTI-WELL & SHELL VIAL CULTURESDiagnostic Hybrids, Inc.1996-08-29730
K941924ELVIS HSVDiagnostic Hybrids, Inc.1995-05-013760
K936271FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTUREDiagnostic Hybrids, Inc.1994-08-262390
K940502FRESH FROZEN CELLSDiagnostic Hybrids, Inc.1994-06-161340
K911345HSV IN SITU DNA PROBE HYBRIDIZATION TEST KITDiagnostic Hybrids, Inc.1991-06-17820
K873529HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KITDiagnostic Hybrids, Inc.1988-08-253590

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda