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510(k) K821135

PREALBUMIN ENZYME IMMUNOASSAY by Abbott Laboratories — Product Code JZJ

K821135 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "PREALBUMIN ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on May 5, 1983. The device falls under product code JZJ (Prealbumin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5060. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1983
Date Received
April 20, 1982
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

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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)
  • K884298 — SPQ(TM) TEST SYSTEM FOR MICROALBUMIN (November 2, 1988)
  • K884297 — SPQ(TM) TEST SYSTEM FOR PREALBUMIN (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)
  • K772329 — LAS-R HUMAN PREALBUMIN TEST (February 3, 1978)

FDA data resources