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510(k) K843426

EOSIN Y 1% ALCOHOLIC by Accra Laboratories, Inc. — Product Code HYB

K843426 is an FDA 510(k) premarket notification submitted by Accra Laboratories, Inc. for the device "EOSIN Y 1% ALCOHOLIC". The FDA issued a decision of Substantially Equivalent on September 27, 1984. The device falls under product code HYB (Eosin Y), a Class I device regulated under 21 CFR 864.1850. Accra Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1984
Date Received
September 4, 1984
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 Accra Laboratories, Inc.

  • K851494 — TWO-STEP ACID FAST BACTERIA STAIN (April 29, 1985)
  • K851493 — KINYOUN ACID FAST STAIN KIT (April 29, 1985)
  • K843427 — GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (October 2, 1984)
  • K843425 — HARRIS HEMATOXYLIN, MERCURY FREE, ACID (October 2, 1984)
  • K843428 — BIOFIX (September 27, 1984)
  • K843429 — GRAM STAIN SET W/STABILIZED IODINE (September 14, 1984)
  • K831090 — HEMATOXYLIN GILL FORMULATION IX#56016 (June 8, 1983)
  • K830542 — HEMAQUIK II STAINING SOLUTION #55961 (March 17, 1983)
  • K823328 — HARRIS HEMATOXYLIN (December 28, 1982)
  • K823329 — PAPINCOLABU STAIN EA-36/50/65 & OG-6 (December 28, 1982)

Other clearances for product code HYB

  • K893663 — INSTANT EOSIN-AQUEOUS (June 13, 1989)
  • K880596 — EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE (March 31, 1988)
  • K880240 — INSTANT EOSIN-ALCOHOLIC (March 3, 1988)
  • 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