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510(k) K884176

CHROMATOGRAPHY KIT by Gelman Sciences, Inc. — Product Code DPA

K884176 is an FDA 510(k) premarket notification submitted by Gelman Sciences, Inc. for the device "CHROMATOGRAPHY KIT". The FDA issued a decision of Substantially Equivalent on April 4, 1989. The device falls under product code DPA (Apparatus, General Use, Thin Layer Chromatography), a Class I device regulated under 21 CFR 862.2270. Gelman Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1989
Date Received
October 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, General Use, Thin Layer Chromatography
Device Class
Class I
Regulation Number
862.2270
Review Panel
TX
Submission Type

Other clearances by Gelman Sciences, Inc.

  • K946190 — DRUG DISPENSING SPIKE (March 17, 1995)
  • K943127 — PHARMASSURE LARGE VOLUME TRANSFER FILTERS (September 29, 1994)
  • K941589 — SYRINGE FILTER DEVICES (September 6, 1994)
  • K941020 — DRUG RECONSTITUTION FILTER DEVICE (August 10, 1994)
  • K942275 — VIAL VENT FILTER (July 26, 1994)
  • K941032 — UNKNOWN (May 27, 1994)
  • K910821 — TRANSDUCER PROTECTOR (August 12, 1991)
  • K892387 — MODIFIED GELMAN ARTERIAL FILTER (June 22, 1989)
  • K884178 — DRUG CONTROL SET (February 17, 1989)
  • K884177 — DRUG STANDARD SET (February 17, 1989)

Other clearances for product code DPA

  • K904326 — DE-TOX TUBES A AND DE-TOX TUBES B (January 17, 1991)
  • K791431 — TECHNICON FAST-LC SYS. FOR THEOPHYLLINE (October 11, 1979)
  • K770765 — REAGENT SET, RENORPACE (June 24, 1977)
  • K760908 — MINIATURE ASCENDING PAPER CHROMATO- (November 19, 1976)

FDA data resources