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510(k) K771780

LAS-R TM by Hyland Therapeutic Div., Travenol Laboratories — Product Code DEB

K771780 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "LAS-R TM". The FDA issued a decision of Substantially Equivalent on October 4, 1977. The device falls under product code DEB (Alpha-2-Macroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5620. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1977
Date Received
September 23, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5620
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 DEB

  • K140664 — HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS (April 16, 2014)
  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K053073 — N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN (March 28, 2006)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K914389 — ALPHA-2 MACROGLOBULIN TEST RID KIT (December 20, 1991)
  • K896483 — QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK (December 1, 1989)
  • K850683 — 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 (November 27, 1985)
  • K851282 — RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI (May 24, 1985)
  • K850603 — SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN (March 5, 1985)
  • K812493 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO (September 23, 1981)

FDA data resources