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510(k) K803094

COPPER SULFATE SOLUTION SP. GR.1.053 by Accra Laboratories, Inc. — Product Code KLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1981
Date Received
December 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
Submission Type

Other clearances by Accra Laboratories, Inc.

  • K851493 — KINYOUN ACID FAST STAIN KIT (April 29, 1985)
  • K851494 — TWO-STEP ACID FAST BACTERIA STAIN (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)
  • 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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