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510(k) K862123

BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE by Marion Laboratories, Inc. — Product Code KZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1986
Date Received
June 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Gas Generating
Device Class
Class I
Regulation Number
866.2580
Review Panel
MI
Submission Type

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  • K874552 — ENVISAN PAD (January 22, 1988)
  • K874551 — ENVINET(TM) (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)
  • K853073 — CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. (August 1, 1985)

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  • K871709 — ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) (May 15, 1987)
  • K871238 — ANABAG (April 3, 1987)
  • K853534 — BBL CAMPY POUCH (August 29, 1985)
  • K845008 — BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE (March 5, 1985)
  • K844571 — CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE (January 30, 1985)
  • K841117 — GASPAK PLUS DISPOS. HYDROGEN & (April 4, 1984)
  • K832229 — BBL ANAGEL POWDER (August 12, 1983)