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510(k) K771879

GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID by Hyland Therapeutic Div., Travenol Laboratories — Product Code DEN

K771879 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID". The FDA issued a decision of Substantially Equivalent on October 19, 1977. The device falls under product code DEN (Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5420. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1977
Date Received
October 4, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5420
Review Panel
IM
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 DEN

  • K780325 — RID SYSTEM-HUMAN C-REACTIVE PROTEIN (March 17, 1978)

FDA data resources