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510(k) K801833

GAS-CHROMATOGRAPHIC PACKING by Supelco, Inc. — Product Code DJA

K801833 is an FDA 510(k) premarket notification submitted by Supelco, Inc. for the device "GAS-CHROMATOGRAPHIC PACKING". The FDA issued a decision of Substantially Equivalent on August 27, 1980. The device falls under product code DJA (Column Supports, Glc), a Class I device regulated under 21 CFR 862.2250. Supelco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1980
Date Received
August 1, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Column Supports, Glc
Device Class
Class I
Regulation Number
862.2250
Review Panel
TX
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)

FDA data resources