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510(k) K884298

SPQ(TM) TEST SYSTEM FOR MICROALBUMIN by Atlantic Antibodies — Product Code JZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1988
Date Received
October 12, 1988
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 Atlantic Antibodies

  • K892526 — SPQ TM TEST SYSTEM II FOR CRP (May 9, 1989)
  • K891154 — SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B (March 16, 1989)
  • K890563 — SPQ(TM) ANTIBODY REAGENT SET II FOR TRF (March 3, 1989)
  • K890561 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGM (February 23, 1989)
  • K890416 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGG (February 22, 1989)
  • K890562 — SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (February 22, 1989)
  • K890564 — SPQ(TM) ANTIBODY REAGENT SET II FOR C4 (February 17, 1989)
  • K890417 — SPQ(TM) ANTIBODY REAGENT SET II FOR C3 (February 17, 1989)
  • K890415 — SPQ(TM) ANTIBODY REAGENT SET II FOR AAT (February 17, 1989)
  • K890560 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGA (February 15, 1989)

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)
  • 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)
  • K772329 — LAS-R HUMAN PREALBUMIN TEST (February 3, 1978)