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510(k) K843050

GRAM STAIN by Reagent Laboratory, Inc. — Product Code JTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1984
Date Received
August 3, 1984
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 Reagent Laboratory, Inc.

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  • K860143 — URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE (February 10, 1986)
  • K842982 — FORMALIN BUFFERED (October 1, 1984)
  • K842785 — STAIN, METHYLENE BLUE-EOSIN (September 11, 1984)
  • K841847 — LITHIUM REAGENT (August 17, 1984)
  • K843051 — WRIGHTS STAIN SOLUTION (August 3, 1984)
  • K841800 — LYSING & HEMOGLOBIN REAGENT (May 31, 1984)
  • K841799 — CYANOMETHEMOGLOBIN REAGENT (May 31, 1984)

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  • K920970 — BACTIDROP KOH (10%) (June 9, 1992)
  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)
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  • 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)