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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
510(k) Number K813449
Device Name PHE/TYR KINETIC UV TEST SET
Applicant
P-L Biochemicals, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
P-L Biochemicals, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1555
Classification Product Code
JNB  
Date Received12/10/1981
Decision Date 12/31/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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