Atlas FDA

URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A

FDA 510(k) clearance K000462 · decided 2000-04-06

Clearance details

K-number
K000462
Device name
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
2000-02-11
Decision date
2000-04-06
Days to decision
55 days
Clearance type
Traditional
Product code
LCM
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Newark, DE, 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
COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003)Dade Behring, Inc.2002-07-24
COBAS INTEGRA CYCLOSPORINE (P920031/S002)Dade Behring, Inc.2002-02-26
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001)Dade Behring, Inc.2000-08-11
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031)Dade Behring, Inc.1996-10-02