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510(k) K831195

WESTERGREN DISPETTE FOR ESR by Ulster Scientific, Inc. — Product Code JPH

K831195 is an FDA 510(k) premarket notification submitted by Ulster Scientific, Inc. for the device "WESTERGREN DISPETTE FOR ESR". The FDA issued a decision of Substantially Equivalent on May 9, 1983. 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
May 9, 1983
Date Received
April 12, 1983
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)
  • K860899 — DISPETTE II (April 14, 1986)
  • K852554 — SRT-SYSTEM (July 18, 1985)
  • K840500 — SEDIPLAST (February 21, 1984)
  • K823761 — ERYTHROCYTE & STAND SEDIMENT. RATE TUBE (January 21, 1983)
  • K823368 — DADE ESR KIT (December 28, 1982)

FDA data resources