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510(k) K880157

MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST by Syva Co. — Product Code GON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1988
Date Received
January 13, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

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Other clearances for product code GON

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  • K780996 — RUBELISA TEST KIT (November 22, 1978)