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510(k) K791118

HLA CONTROL SERA by Calbiochem-Behring Corp. — Product Code LGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1979
Date Received
June 15, 1979
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

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  • K820088 — AFT SYSTEM PROFICIENCY TESTING PROGRAM (January 26, 1982)
  • K812458 — PADAC (September 23, 1981)
  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K810309 — RUBELLA ANTIBODIES TEST REAGENTS (March 11, 1981)

Other clearances for product code LGO

  • K894947 — PLATELIA TOXO IGG KIT (March 23, 1990)
  • K874544 — SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT (August 12, 1988)
  • K761009 — LYMPHOCYTE TYPING, POSITIVE CONTROL (April 6, 1977)
  • K761008 — LYMPHOCYTE TYPING, NEGATIVE CONTROL (April 6, 1977)