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510(k) K860899

DISPETTE II by Ulster Scientific, Inc. — Product Code JPH

K860899 is an FDA 510(k) premarket notification submitted by Ulster Scientific, Inc. for the device "DISPETTE II". The FDA issued a decision of Substantially Equivalent on April 14, 1986. The device falls under product code JPH (Test, Erythrocyte Sedimentation Rate), a Class I device regulated under 21 CFR 864.6700. Ulster Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1986
Date Received
March 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Erythrocyte Sedimentation Rate
Device Class
Class I
Regulation Number
864.6700
Review Panel
HE
Submission Type

Other clearances by Ulster Scientific, Inc.

  • K942620 — FEATHER-TOUCH SINGLE-STICK DEVICE (June 22, 1994)
  • K920562 — UNISTIK (March 27, 1992)
  • K902592 — EPC ELECTRONIC PIPETTING SYSTEM (July 19, 1990)
  • K895890 — AUTOPEN (February 16, 1990)
  • K894474 — THE AUTOLET LITE (August 18, 1989)
  • K885340 — AIR DISPLACEMENT PIPETTE (February 14, 1989)
  • K875354 — UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM (February 17, 1988)
  • K871571 — NEUROTIPS(TM) (June 18, 1987)
  • K871076 — WINPETTE (March 23, 1987)
  • K870078 — ACCUPEN(R) (March 17, 1987)

Other clearances for product code JPH

  • K871076 — WINPETTE (March 23, 1987)
  • K852554 — SRT-SYSTEM (July 18, 1985)
  • K840500 — SEDIPLAST (February 21, 1984)
  • K831195 — WESTERGREN DISPETTE FOR ESR (May 9, 1983)
  • K823761 — ERYTHROCYTE & STAND SEDIMENT. RATE TUBE (January 21, 1983)
  • K823368 — DADE ESR KIT (December 28, 1982)

FDA data resources