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510(k) K820996

SALMONELLA & SHIGELLA GROUPING SERA by Fisher Scientific Co., LLC — Product Code GRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1982
Date Received
April 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Groups, Salmonella Spp.
Device Class
Class II
Regulation Number
866.3550
Review Panel
MI
Submission Type

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  • K863224 — HEMATALL-C PLUS HEMATOLOGY CONTROLS (October 29, 1986)
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Other clearances for product code GRL

  • K945839 — SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA (March 7, 1995)