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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Bite
510(k) Number K861893
Device Name GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
Applicant
Hi Chem, Inc.
231 N. Puente St.
P.O. Box 1599
Brea,  CA  92621
Applicant Contact ANDREW ESTRADA
Correspondent
Hi Chem, Inc.
231 N. Puente St.
P.O. Box 1599
Brea,  CA  92621
Correspondent Contact ANDREW ESTRADA
Regulation Number882.5070
Classification Product Code
JXL  
Date Received05/16/1986
Decision Date 06/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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