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510(k) K813191

SHIGELLA SERA-CHEK by Lab Ability, Inc. — Product Code LIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1981
Date Received
November 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Groups, Shigella Spp.
Device Class
Class II
Regulation Number
866.3660
Review Panel
MI
Submission Type

Other clearances by Lab Ability, Inc.

  • K833407 — SELECTO-DISC NOVOBIOCIN 5UG (December 30, 1983)
  • K832436 — SELECTRO-DISC (September 26, 1983)
  • K830133 — Q-CHECK CULTI-LOOPS (February 9, 1983)
  • K830134 — Q-CHECK REAGENT STANDARDS (January 9, 1983)