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510(k) K875181

MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM by Marion Laboratories, Inc.

K875181 is an FDA 510(k) premarket notification submitted by Marion Laboratories, Inc. for the device "MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM". The FDA issued a decision of Substantially Equivalent on May 27, 1988. Marion Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1988
Date Received
December 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Marion Laboratories, Inc.

  • K883391 — POLYMER ADHESIVE BANDAGE (March 23, 1989)
  • K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN (July 5, 1988)
  • K874554 — ENVICLUSIVE (TM) (March 11, 1988)
  • 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)
  • K862123 — BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (June 16, 1986)
  • K853073 — CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. (August 1, 1985)

FDA data resources