FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)

K Number: K924552 · Decision Dec 7, 1992
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
82
Applicant Total
253
Review Days
89

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Basic Information

Device Name
DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)
K Number
K924552
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.1900
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Date Received
September 9, 1992
Decision Date
December 7, 1992
Product Code
IXW
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
IXW Processor, Radiographic-Film, Automatic

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (IXW), ordered by most recent decision date.

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Other Clearances by E.I. Dupont DE Nemours & Co., Inc.

K Number Device Name
K951851 ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
K953725 CRONEX RADIATION THERAPY VERIFICATION CASSETTE
K953724 CRONEX RADIATION THERAPY CASSETTE
K951441 DUPONT ACA DIGOXIN (DGN A) METHOD
K950137 URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950136 URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950181 URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
K950135 URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950182 URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
K950134 URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
Search all 253 clearances from E.I. Dupont DE Nemours & Co., Inc. →