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510(k) K882637

ACCU-CULSHURE TM by Accu-Med Corp. — Product Code JTX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1988
Date Received
June 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transport Systems, Anaerobic
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

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  • K781376 — STANDARDIZE TGCL & TGCH (September 14, 1978)
  • K780159 — ANASWAB (February 13, 1978)
  • K761241 — PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE (December 30, 1976)
  • K760063 — SPECIMEN COLLECTOR, ANAEROBIC (August 3, 1976)