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510(k) K893663

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

K893663 is an FDA 510(k) premarket notification submitted by Shandon, Inc. for the device "INSTANT EOSIN-AQUEOUS". The FDA issued a decision of Substantially Equivalent on June 13, 1989. 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
June 13, 1989
Date Received
May 15, 1989
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.

  • K890984 — LINISTAIN SLS (April 4, 1989)
  • K880240 — INSTANT EOSIN-ALCOHOLIC (March 3, 1988)
  • K873107 — INSTANT HEMATOXYLIN (August 21, 1987)
  • K780261 — COVERSLIPPER (April 18, 1978)

Other clearances for product code HYB

  • K880596 — EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE (March 31, 1988)
  • K880240 — INSTANT EOSIN-ALCOHOLIC (March 3, 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