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510(k) K874544

SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT by Molecular Biosystems, Inc. — Product Code LGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1988
Date Received
November 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Leukocyte Typing
Device Class
Class I
Regulation Number
864.7675
Review Panel
HE
Submission Type

Other clearances by Molecular Biosystems, Inc.

  • K873670 — SNAP CAMPYLOBACTOR DIAGNOSTIC KIT (June 8, 1988)
  • K873565 — SNAP(R) ROTAVIRUS DIAGNOSTIC KIT (May 13, 1988)
  • K873932 — THE EXTRACTOR(TM) (November 20, 1987)

Other clearances for product code LGO

  • K894947 — PLATELIA TOXO IGG KIT (March 23, 1990)
  • K791118 — HLA CONTROL SERA (August 3, 1979)
  • K761009 — LYMPHOCYTE TYPING, POSITIVE CONTROL (April 6, 1977)
  • K761008 — LYMPHOCYTE TYPING, NEGATIVE CONTROL (April 6, 1977)