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510(k) K890417

SPQ(TM) ANTIBODY REAGENT SET II FOR C3 by Atlantic Antibodies — Product Code KTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1989
Date Received
January 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Complement
Device Class
Class I
Regulation Number
866.4100
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)
  • K890562 — SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (February 22, 1989)
  • K890416 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGG (February 22, 1989)
  • K890415 — SPQ(TM) ANTIBODY REAGENT SET II FOR AAT (February 17, 1989)
  • K890564 — SPQ(TM) ANTIBODY REAGENT SET II FOR C4 (February 17, 1989)
  • K890560 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGA (February 15, 1989)
  • K884297 — SPQ(TM) TEST SYSTEM FOR PREALBUMIN (November 2, 1988)

Other clearances for product code KTQ

  • K812522 — RABBIT COMPLEMENT (September 23, 1981)
  • K812370 — GUINEA PIG COMPLEMENT REGULAR (September 8, 1981)
  • K812369 — GUINEA PIG COMPLEMENT VIRUS ANTIBODY (September 8, 1981)
  • K791117 — RABBIT COMPLEMENT (August 3, 1979)
  • K790380 — LOW-TOX-H RABBIT COMPLEMENT (March 21, 1979)