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510(k) K761156

AMINOGLYCOSIDE CONTROLS by Supelco, Inc. — Product Code DAS

K761156 is an FDA 510(k) premarket notification submitted by Supelco, Inc. for the device "AMINOGLYCOSIDE CONTROLS". The FDA issued a decision of Substantially Equivalent on December 9, 1976. The device falls under product code DAS (Igg (Fc Fragment Specific), Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5530. Supelco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1976
Date Received
November 29, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg (Fc Fragment Specific), Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5530
Review Panel
IM
Submission Type

Other clearances by Supelco, Inc.

  • K894141 — LIQUID CHROMATOGRAPHY COLUMNS (August 21, 1989)
  • K884403 — LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE (December 22, 1988)
  • K883615 — LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 (December 16, 1988)
  • K881868 — LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD (August 29, 1988)
  • K881361 — SOLID PHASE EXTRACTION TUBES (August 8, 1988)
  • K880724 — LIQUID CHROMATO. COLUMNS (May 27, 1988)
  • K874824 — CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (January 21, 1988)
  • K871174 — 4-9295 BARBITURATES TEST MIX (June 11, 1987)
  • K862542 — CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (August 4, 1986)
  • K862541 — LIQUID CHROMATOGRAPHY COLUMNS (July 29, 1986)

Other clearances for product code DAS

  • K982023 — PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT (September 4, 1998)
  • K944876 — HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT (December 15, 1994)
  • K943205 — HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (September 7, 1994)
  • K943098 — HUMAN IGG SUBCLASSES ELISA COMBI KIT (September 7, 1994)
  • K895600 — HUMAN (IGG) SUBCLASS (EIA) KIT (November 8, 1989)
  • K790708 — ANTISERUM TO HUMAN IG G FC FRAGMENTS (August 22, 1979)
  • K790715 — ANTISERUM TO HUMAN FC (August 16, 1979)

FDA data resources