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510(k) K790815

CULTURETTE BRAND PVA by Marion Laboratories, Inc. — Product Code IGM

K790815 is an FDA 510(k) premarket notification submitted by Marion Laboratories, Inc. for the device "CULTURETTE BRAND PVA". The FDA issued a decision of Substantially Equivalent on May 15, 1979. The device falls under product code IGM (Solution, Carnoy'S), a Class I device regulated under 21 CFR 864.4010. Marion Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1979
Date Received
April 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Carnoy'S
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
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 IGM

  • K842737 — CARNOY'S SOLUTION (September 7, 1984)
  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)

FDA data resources