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510(k) K842982

FORMALIN BUFFERED by Reagent Laboratory, Inc. — Product Code IFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1984
Date Received
July 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formalin, Neutral Buffered
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
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)
  • K843050 — GRAM STAIN (September 11, 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)

Other clearances for product code IFP

  • K884755 — CONSED FECAL CONCENTRATION SYSTEM (January 10, 1989)
  • K872663 — DRY-FORM (August 6, 1987)
  • K872140 — (MSI) PATH-SAVER (June 15, 1987)
  • K870852 — NBF 10% NEUTRAL BUFFERED FORMALIN (March 31, 1987)
  • K853497 — PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN (August 28, 1985)
  • K842940 — CBA FORMALIN (August 28, 1984)
  • K842728 — BUF-FIX (August 3, 1984)
  • K840926 — FORMALIN SOLUTION 10% NEUTRAL BUFFER (March 12, 1984)
  • K830583 — NEUTRAL BUFFERED FORMALIN 10% (March 17, 1983)
  • K830582 — MILLONIG'S MODIFIED PHOSPHATE BUFFERED (March 17, 1983)