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510(k) K911826

IMMUNOCARD HCG ONE STEP (I-S) TEST KIT by Disease Detection International, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1991
Date Received
April 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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  • K884246 — MODIFIED DDI SEROCARD HERPES IGG TEST KIT (April 10, 1989)

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