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510(k) K863164

AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA by Precision Dynamics Corp. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1986
Date Received
August 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

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  • K874665 — SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY (January 20, 1988)
  • K873369 — SECURLINE FRANSEENE NEEDLE (October 20, 1987)
  • K872507 — PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II (July 9, 1987)
  • K851364 — FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP (April 22, 1985)

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