QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT


Device Classification Name

ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine

510(k) Number K000754
Device Name QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
Original Applicant
QUANTASE LTD.
3 riverview business park
friarton road
perth, scotland, 

GB

ph2 8df

Original Contact r. stewart campbell
Regulation Number 862.1555
Classification Product Code
JNB  
Date Received 03/08/2000
Decision Date 06/19/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls