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510(k) K872507

PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II by Precision Dynamics Corp. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1987
Date Received
June 24, 1987
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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  • K863164 — AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA (August 27, 1986)
  • K851364 — FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP (April 22, 1985)

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