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510(k) K823761

ERYTHROCYTE & STAND SEDIMENT. RATE TUBE by Cordis Corp. — Product Code JPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1983
Date Received
December 14, 1982
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

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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)
  • K831195 — WESTERGREN DISPETTE FOR ESR (May 9, 1983)
  • K823368 — DADE ESR KIT (December 28, 1982)