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510(k) K812919

MULTI-GRAM DEVELOPING TANK R-12 & R-3 by Marion Laboratories, Inc. — Product Code DKK

K812919 is an FDA 510(k) premarket notification submitted by Marion Laboratories, Inc. for the device "MULTI-GRAM DEVELOPING TANK R-12 & R-3". The FDA issued a decision of Substantially Equivalent on November 2, 1981. The device falls under product code DKK (Tanks, Developing, Tlc), a Class I device regulated under 21 CFR 862.2270. Marion Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1981
Date Received
October 19, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tanks, Developing, Tlc
Device Class
Class I
Regulation Number
862.2270
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