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510(k) K931474

DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS by Gbf Medical Group — Product Code KDW

Clearance Details

Decision: SESK (Substantially Equivalent (kit))
Decision Date: May 10, 1994
Date Received: March 24, 1993
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
Device Class: Class I
Regulation Number: 864.3250
Review Panel: PA
Submission Type