Atlas FDA

CORDISNHYPERION HEMOGLOBIN A1 TEST SYS

FDA 510(k) clearance K812242 · decided 1981-09-09

Clearance details

K-number
K812242
Device name
CORDISNHYPERION HEMOGLOBIN A1 TEST SYS
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1981-08-11
Decision date
1981-09-09
Days to decision
29 days
Clearance type
Traditional
Product code
LCP
Device class
2
Regulation number
864.7470
Medical specialty
Hematology
Advisory committee
Hematology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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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