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510(k) K843050

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

K843050 is an FDA 510(k) premarket notification submitted by Reagent Laboratory, Inc. for the device "GRAM STAIN". The FDA issued a decision of Substantially Equivalent on September 11, 1984. The device falls under product code JTS (Stains, Microbiologic), a Class I device regulated under 21 CFR 864.1850. Reagent Laboratory, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K863502 — SOLUTION B- NA 50MEQ/L, K 40 MEQ/L (October 21, 1986)
  • K863503 — HEMOLYSE (October 3, 1986)
  • K863550 — POTASSIUM HYDROXIDE 10% W/V (October 2, 1986)
  • 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)
  • K841799 — CYANOMETHEMOGLOBIN REAGENT (May 31, 1984)
  • K841800 — LYSING & HEMOGLOBIN REAGENT (May 31, 1984)

Other clearances for product code JTS

  • K960090 — CALCOFLUOR WHITE STAIN KIT (March 19, 1996)
  • K960095 — BACTIDROP CALCOFLUOR WHITE (March 19, 1996)
  • K920976 — BACTIDROP INDIA INK (June 9, 1992)
  • K920970 — BACTIDROP KOH (10%) (June 9, 1992)
  • K920975 — BACTIDROP CALCOFLUOR WHITE (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