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510(k) K991316

TOUCH TEAR IGE MICROASSAY KIT by Touch Scientific, Inc. — Product Code DGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1999
Date Received
April 19, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Touch Scientific, Inc.

  • K934473 — LACTOFERRIN MICROASSAY SYSTEM (December 3, 1993)
  • K931901 — LACTOCARD (July 6, 1993)

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