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510(k) K882637

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

K882637 is an FDA 510(k) premarket notification submitted by Accu-Med Corp. for the device "ACCU-CULSHURE TM". The FDA issued a decision of Substantially Equivalent on July 6, 1988. The device falls under product code JTX (Transport Systems, Anaerobic), a Class I device regulated under 21 CFR 866.2900.

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

Other clearances for product code JTX

  • K901645 — ANAEROBIC ACCU-CULSHURE(TM) (July 16, 1990)
  • K897151 — ACUSON V328 AND C5432 TRANSDUCERS (July 3, 1990)
  • K791724 — BIO-BAG ENVIRONMENTAL CHAMBER (A & B) (October 17, 1979)
  • 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)

FDA data resources