Atlas FDA

PSYCHEMEDICS RIA COCAINE ASSAY

FDA 510(k) clearance K010868 · decided 2001-11-06

Clearance details

K-number
K010868
Device name
PSYCHEMEDICS RIA COCAINE ASSAY
Applicant
Psychemedics Corp.
Decision
Substantially Equivalent
Date received
2001-03-23
Decision date
2001-11-06
Days to decision
228 days
Clearance type
Traditional
Product code
KLN
Device class
2
Regulation number
862.3250
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Culver City, CA, 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
URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) (K913867)Immunalysis Corporation1991-09-19
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE (K913722)Roche Diagnostic Systems, Inc.1991-09-10
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE (K912756)Roche Diagnostic Systems, Inc.1991-07-26
TARGET COCAINE METABOLITE-R (K910122)V-Tech, Inc.1991-03-19
TARGET COCAINE METABOLITE-V (K910123)V-Tech, Inc.1991-03-19
MILENIA COCAINE METABOLITE (K910044)Diagnostic Products Corp.1991-02-13
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) (K905730)Roche Diagnostic Systems, Inc.1991-01-15
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE (K904995)Roche Diagnostic Systems, Inc.1990-11-28
MICROMEDIC CRACKPOT RIA KIT (K880674)Icn Micromedic Systems1988-10-06
RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] (K871549)Immunalysis Corporation1987-06-16
COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 (K870740)Diagnostic Products Corp.1987-03-19
DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT (K862218)Diagnostic Products Corp.1986-06-27

Recalls involving this device

No recalls on record reference this clearance.