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510(k) K880240

INSTANT EOSIN-ALCOHOLIC by Shandon, Inc. — Product Code HYB

K880240 is an FDA 510(k) premarket notification submitted by Shandon, Inc. for the device "INSTANT EOSIN-ALCOHOLIC". The FDA issued a decision of Substantially Equivalent on March 3, 1988. The device falls under product code HYB (Eosin Y), a Class I device regulated under 21 CFR 864.1850. Shandon, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1988
Date Received
January 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Eosin Y
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Shandon, Inc.

  • K893663 — INSTANT EOSIN-AQUEOUS (June 13, 1989)
  • K890984 — LINISTAIN SLS (April 4, 1989)
  • K873107 — INSTANT HEMATOXYLIN (August 21, 1987)
  • K780261 — COVERSLIPPER (April 18, 1978)

Other clearances for product code HYB

  • K893663 — INSTANT EOSIN-AQUEOUS (June 13, 1989)
  • K880596 — EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE (March 31, 1988)
  • K843426 — EOSIN Y 1% ALCOHOLIC (September 27, 1984)
  • K822982 — MIDAS 100 HEMACOLOR STAIN #66030 (October 27, 1982)
  • K821574 — EOSIN Y SOLUTIN, AGUEOUS (June 10, 1982)
  • K821573 — EOSIN Y SOLUTION ALCHOLIC (June 9, 1982)
  • K811797 — EOSIN-Y (July 28, 1981)
  • K811826 — EOSIN Y (July 10, 1981)
  • K800942 — VOLU-SOL EOSIN Y STAIN (May 8, 1980)

FDA data resources