Home / 510(k) Clearances / K811067

510(k) K811067

BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M by Marion Laboratories, Inc. — Product Code KZT

K811067 is an FDA 510(k) premarket notification submitted by Marion Laboratories, Inc. for the device "BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M". The FDA issued a decision of Substantially Equivalent on April 29, 1981. The device falls under product code KZT (Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin), a Class II device regulated under 21 CFR 862.3450. Marion Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1981
Date Received
April 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
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)

FDA data resources