CORDIA A
FDA 510(k) clearance K810046 · decided 1981-02-25
Clearance details
- K-number
- K810046
- Device name
- CORDIA A
- Applicant
- Cordis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-01-12
- Decision date
- 1981-02-25
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- KHW
- Device class
- 2
- Regulation number
- 866.3220
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| ENTAMOEBA TEST (K944791) | Techlab, Inc. | 1995-03-09 |
| DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA (K900604) | Biovir Laboratories, Inc. | 1990-07-26 |
| GIARDEIA(TM) (K890774) | Antibodies, Inc. | 1989-04-04 |
| GIARDIA STOOL ANTIGEN TEST KIT (K890003) | Lmd Laboratories | 1989-03-14 |
| PROSPECT/GIARDIA (K874849) | Alexon Biomedical, Inc. | 1988-01-05 |
| AMEBIASIS ELISA TEST KIT (K870318) | Lmd Laboratories | 1987-08-11 |
| AMEBIASIS MICROASSAY (K863811) | Diamedix Corp. | 1986-10-09 |
| PDQ AMEBIASIS (K862473) | Diamedix Corp. | 1986-08-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |