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510(k) K781062

DROPPER, SOLUTION TRICHROME, CEPTI-SEAL by Marion Laboratories, Inc. — Product Code HYW

K781062 is an FDA 510(k) premarket notification submitted by Marion Laboratories, Inc. for the device "DROPPER, SOLUTION TRICHROME, CEPTI-SEAL". The FDA issued a decision of Substantially Equivalent on August 14, 1978. The device falls under product code HYW (Stain, Trichrome, Mallory'S), a Class I device regulated under 21 CFR 864.1850. Marion Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
June 26, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stain, Trichrome, Mallory'S
Device Class
Class I
Regulation Number
864.1850
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 HYW

  • K792706 — PARA-PAK(WHEATLEY'S TRICHROME STAIN) (January 24, 1980)

FDA data resources