Atlas FDA

CORDIA HS ANTIBODY TYPING REAGENTS

FDA 510(k) clearance K843751 · decided 1985-04-24

Clearance details

K-number
K843751
Device name
CORDIA HS ANTIBODY TYPING REAGENTS
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1984-09-25
Decision date
1985-04-24
Days to decision
211 days
Clearance type
Traditional
Product code
GQN
Device class
2
Regulation number
866.3305
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Miami, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 (K070265)Diagnostic Hybrids, Inc.2007-10-24
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 (K063798)Diagnostic Hybrids, Inc.2007-09-21
LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY (K991880)Light Diagnostics1999-11-09
ELVIS HSV ID/TYPING TEST SYSTEM (K971662)Diagnostic Hybrids, Inc.1997-11-18
HSV-1 ANTIGEN CONTROL SLIDES (K964874)Viral Antigens, Inc.1997-07-01
HSV-2 ANTIGEN CONTROL SLIDES (K971101)Viral Antigens, Inc.1997-07-01
ELVIS HSV GOLD (K960578)Diagnostic Hybrids, Inc.1996-09-05
ELVIS HSV (K941924)Diagnostic Hybrids, Inc.1995-05-01
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT (K911345)Diagnostic Hybrids, Inc.1991-06-17
MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. (K884761)Difco Laboratories, Inc.1988-12-05
HERPES VIRUS CONTROL SLIDES (K883684)Val Tech Diagnostics, Inc.1988-09-28
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT (K873529)Diagnostic Hybrids, Inc.1988-08-25

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086)Cordis Corp.2014-10-10
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082)Cordis Corp.2012-01-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085)Cordis Corp.2012-01-26
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059)Cordis Corp.2011-05-27
CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083)Cordis Corp.2011-05-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081)Cordis Corp.2011-03-03
CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026)Cordis Corp.2011-02-22
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078)Cordis Corp.2010-09-02