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510(k) K851494

TWO-STEP ACID FAST BACTERIA STAIN by Accra Laboratories, Inc. — Product Code JTS

K851494 is an FDA 510(k) premarket notification submitted by Accra Laboratories, Inc. for the device "TWO-STEP ACID FAST BACTERIA STAIN". The FDA issued a decision of Substantially Equivalent on April 29, 1985. The device falls under product code JTS (Stains, Microbiologic), 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
April 29, 1985
Date Received
April 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Microbiologic
Device Class
Class I
Regulation Number
864.1850
Review Panel
MI
Submission Type

Other clearances by Accra Laboratories, Inc.

  • K851493 — KINYOUN ACID FAST STAIN KIT (April 29, 1985)
  • K843425 — HARRIS HEMATOXYLIN, MERCURY FREE, ACID (October 2, 1984)
  • K843427 — GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (October 2, 1984)
  • K843426 — EOSIN Y 1% ALCOHOLIC (September 27, 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 JTS

  • K960090 — CALCOFLUOR WHITE STAIN KIT (March 19, 1996)
  • K960095 — BACTIDROP CALCOFLUOR WHITE (March 19, 1996)
  • K920975 — BACTIDROP CALCOFLUOR WHITE (June 9, 1992)
  • K920976 — BACTIDROP INDIA INK (June 9, 1992)
  • K920970 — BACTIDROP KOH (10%) (June 9, 1992)
  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)
  • K890861 — ATS DOBELL & O'CONNOR'S IODINE (March 23, 1989)
  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)

FDA data resources