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510(k) K883430

PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST by Disease Detection International, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1989
Date Received
August 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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  • K884249 — MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT (April 10, 1989)
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