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510(k) K791724

BIO-BAG ENVIRONMENTAL CHAMBER (A & B) by Marion Laboratories, Inc. — Product Code JTX

K791724 is an FDA 510(k) premarket notification submitted by Marion Laboratories, Inc. for the device "BIO-BAG ENVIRONMENTAL CHAMBER (A & B)". The FDA issued a decision of Substantially Equivalent on October 17, 1979. The device falls under product code JTX (Transport Systems, Anaerobic), a Class I device regulated under 21 CFR 866.2900. Marion Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1979
Date Received
August 30, 1979
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 by Marion Laboratories, Inc.

  • K883391 — POLYMER ADHESIVE BANDAGE (March 23, 1989)
  • K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN (July 5, 1988)
  • K875181 — MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM (May 27, 1988)
  • K874554 — ENVICLUSIVE (TM) (March 11, 1988)
  • K874551 — ENVINET(TM) (January 22, 1988)
  • K874552 — ENVISAN PAD (January 22, 1988)
  • K874553 — ENVISAN PASTE (December 18, 1987)
  • K870864 — CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST (April 14, 1987)
  • K863485 — MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST (September 17, 1986)
  • K862123 — BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (June 16, 1986)

Other clearances for product code JTX

  • K901645 — ANAEROBIC ACCU-CULSHURE(TM) (July 16, 1990)
  • K897151 — ACUSON V328 AND C5432 TRANSDUCERS (July 3, 1990)
  • K882637 — ACCU-CULSHURE TM (July 6, 1988)
  • 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