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510(k) K820192

HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM by Hyland Therapeutic Div., Travenol Laboratories — Product Code GRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1982
Date Received
January 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, H. Influenza
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

Other clearances by Hyland Therapeutic Div., Travenol Laboratories

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  • 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)
  • K780785 — DILUTOR TRANSPORTER (June 14, 1978)

Other clearances for product code GRP

  • K884967 — BACTIGEN(R) H. INFLUENZAE TYPE B (February 7, 1989)
  • K854490 — IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES (December 27, 1985)
  • K831525 — H-FLU B ELISA TEST (September 29, 1983)
  • K823348 — H. INFLUENZA B ANTISERA FOR CIE (December 28, 1982)
  • K821266 — BBL DIRECTIGEN MENINGITIS TEST KIT (June 1, 1982)