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510(k) K883235

RAPIDTEST-HCG (TM) by Synbiotics Corp. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1988
Date Received
August 1, 1988
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

Other clearances by Synbiotics Corp.

  • K873784 — NOVA STREP A (November 12, 1987)
  • K862354 — MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT (September 29, 1986)

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