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510(k) K781869

DROPPER, CEPTI-SEAL KOH SOLUTION by Marion Laboratories, Inc. — Product Code KEQ

K781869 is an FDA 510(k) premarket notification submitted by Marion Laboratories, Inc. for the device "DROPPER, CEPTI-SEAL KOH SOLUTION". The FDA issued a decision of Substantially Equivalent on November 22, 1978. The device falls under product code KEQ (Media, Mounting, Water Soluble), 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
November 22, 1978
Date Received
November 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Mounting, Water Soluble
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 KEQ

  • K830515 — SCOTTS TAP WATER SUBSTITUTE CONCENTRATE (March 31, 1983)
  • K792709 — KOH MOUNTING FLUID W/GLYCEROL (January 24, 1980)
  • K792703 — LACTO-PHENOL ANALINE BLUE FLUID (January 24, 1980)
  • K792702 — VASPAR SEALANT (January 24, 1980)
  • K781868 — DROPPER, CEPTI-SEAL LAVTOPHENOL (November 22, 1978)
  • K781388 — F.A. MOUNTING MEDIUM (August 21, 1978)

FDA data resources