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510(k) K822602

HEMACOUNT WRIGHT GIEMSA STAIN PACK by Accra Laboratories, Inc. — Product Code JAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1982
Date Received
August 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type

Other clearances by Accra Laboratories, Inc.

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  • K843425 — HARRIS HEMATOXYLIN, MERCURY FREE, ACID (October 2, 1984)
  • K843428 — BIOFIX (September 27, 1984)
  • K843426 — EOSIN Y 1% ALCOHOLIC (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)
  • K823329 — PAPINCOLABU STAIN EA-36/50/65 & OG-6 (December 28, 1982)

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