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510(k) K842728

BUF-FIX by E K Ind., Inc. — Product Code IFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1984
Date Received
July 13, 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 E K Ind., Inc.

  • K842931 — DRABKIN REAGENT (September 21, 1984)
  • K842938 — ACETIC ACID 1% V/V (September 14, 1984)
  • K842934 — DECOLORIZING FLUIC, ACID-ALCOHOL 3% (September 12, 1984)
  • K842936 — ACETIC ACID, 3% V/V (September 12, 1984)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)
  • K842935 — ACETIC ACID, 5% V/V (September 12, 1984)
  • K842928 — JENNER BLOOD STAIN (September 11, 1984)
  • K842739 — PAP STAIN, EA-36 (September 11, 1984)
  • K842933 — CARBOL-FUCHSIN, ZIEHL-NEEDSEN (September 11, 1984)
  • K842927 — LIGHT GREEN SF 1% (September 11, 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)
  • K842982 — FORMALIN BUFFERED (October 1, 1984)
  • K842940 — CBA FORMALIN (August 28, 1984)
  • K840926 — FORMALIN SOLUTION 10% NEUTRAL BUFFER (March 12, 1984)
  • K830582 — MILLONIG'S MODIFIED PHOSPHATE BUFFERED (March 17, 1983)
  • K830583 — NEUTRAL BUFFERED FORMALIN 10% (March 17, 1983)