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510(k) K873986

BETA-HCG ASSAY by Schiff & Co. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1988
Date Received
September 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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  • K943521 — VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE (February 14, 1995)
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  • K192547 — MAGLUMI 2000 HCG/ß-HCG (January 17, 2020)
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