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510(k) K761008

LYMPHOCYTE TYPING, NEGATIVE CONTROL by Hyland Therapeutic Div., Travenol Laboratories — Product Code LGO

K761008 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "LYMPHOCYTE TYPING, NEGATIVE CONTROL". The FDA issued a decision of Substantially Equivalent on April 6, 1977. The device falls under product code LGO (Test, Leukocyte Typing), a Class I device regulated under 21 CFR 864.7675. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1977
Date Received
November 2, 1976
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 Hyland Therapeutic Div., Travenol Laboratories

  • K820835 — ALUMINA SILICA-ACTIVATED PARTIAL THROM (April 26, 1982)
  • K820192 — HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (March 11, 1982)
  • K812220 — NEPHELOMETRIC SOLID TURBIDITY STANDARD (August 18, 1981)
  • K810078 — Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S (February 2, 1981)
  • K810077 — OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. (January 28, 1981)
  • K802610 — ALERT A,HDL-APOLIPOROTEIN A, TEST KIT (January 5, 1981)
  • K791113 — LOW IONIC STRENGTH SOLUTION (LISS) (June 28, 1979)
  • K790249 — TEST CELLS (May 16, 1979)
  • K781225 — GLOBULIN TEST, HUMAN THYROXINE BINDING (August 31, 1978)
  • K780962 — AUTOMATED ENZYME (July 27, 1978)

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)
  • K791118 — HLA CONTROL SERA (August 3, 1979)
  • K761009 — LYMPHOCYTE TYPING, POSITIVE CONTROL (April 6, 1977)

FDA data resources