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510(k) K861336

IAP PLATE TEST by Scientific Sales Intl., Inc. — Product Code LKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1986
Date Received
April 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5420
Review Panel
IM
Submission Type

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  • K853285 — MYWASHER 5 (October 4, 1985)
  • K853284 — MYREADER 7 (October 4, 1985)
  • K853380 — SPR 2 AUTODILUTER (September 12, 1985)
  • K853379 — PLATE INCUBATOR (September 3, 1985)
  • K833022 — AIR UTERINE DISPLACER-AUD 120 (October 14, 1983)
  • K802416 — SALEM/RESCE INTUBATION GUIDE (October 23, 1980)

Other clearances for product code LKL

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  • K922417 — AL-ACID GLYCOPROTEIN RID KIT (August 20, 1992)
  • K904175 — RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT (November 13, 1990)
  • K884217 — TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN (November 4, 1988)
  • K873868 — ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) (October 20, 1987)
  • K862087 — SANTEST 1AP (December 3, 1986)
  • K841734 — TAGO FIFFU-GEN, OROSOMUCOID (June 1, 1984)
  • K831960 — TEST FOR HUMAN ALPHA ONE ACID GLYCO- (July 19, 1983)