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510(k) K772329

LAS-R HUMAN PREALBUMIN TEST by Hyland Therapeutic Div., Travenol Laboratories — Product Code JZJ

K772329 is an FDA 510(k) premarket notification submitted by Hyland Therapeutic Div., Travenol Laboratories for the device "LAS-R HUMAN PREALBUMIN TEST". The FDA issued a decision of Substantially Equivalent on February 3, 1978. The device falls under product code JZJ (Prealbumin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5060. Hyland Therapeutic Div., Travenol Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1978
Date Received
December 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prealbumin, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5060
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 JZJ

  • K000661 — RANDOX PREALBUMIN (April 13, 2000)
  • K972638 — TINA-QUANT PREALBUMIN (January 9, 1998)
  • K951966 — HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (June 1, 1995)
  • K913672 — PREALBUMIN IMMUNOLOGICAL NL TEST KIT (December 20, 1991)
  • K884297 — SPQ(TM) TEST SYSTEM FOR PREALBUMIN (November 2, 1988)
  • K884298 — SPQ(TM) TEST SYSTEM FOR MICROALBUMIN (November 2, 1988)
  • K883002 — QM300 PREALBUMIN ANTIBODY PACK (September 22, 1988)
  • K850686 — ANTISERUM TO HUMAN PREALBUMIN (November 1, 1985)
  • K851912 — LASER PREALBUMIN TEST (June 21, 1985)
  • K821135 — PREALBUMIN ENZYME IMMUNOASSAY (May 5, 1983)

FDA data resources