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510(k) K840500

SEDIPLAST by Precision Technology, Inc. — Product Code JPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
February 6, 1984
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 Precision Technology, Inc.

  • K840502 — CATS-CLINICAL LAB COMPUTER SOFTWARE- (April 4, 1984)
  • K840501 — ACCULAB SUPPLIES CHEMICAL ANALYZERS (April 4, 1984)

Other clearances for product code JPH

  • K871076 — WINPETTE (March 23, 1987)
  • K860899 — DISPETTE II (April 14, 1986)
  • K852554 — SRT-SYSTEM (July 18, 1985)
  • K831195 — WESTERGREN DISPETTE FOR ESR (May 9, 1983)
  • K823761 — ERYTHROCYTE & STAND SEDIMENT. RATE TUBE (January 21, 1983)
  • K823368 — DADE ESR KIT (December 28, 1982)