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510(k) K884755

CONSED FECAL CONCENTRATION SYSTEM by Donald L. Price, Ph.D. — Product Code IFP

K884755 is an FDA 510(k) premarket notification submitted by Donald L. Price, Ph.D. for the device "CONSED FECAL CONCENTRATION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 10, 1989. The device falls under product code IFP (Formalin, Neutral Buffered), a Class I device regulated under 21 CFR 864.4010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1989
Date Received
November 14, 1988
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 for product code IFP

  • 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)
  • 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)

FDA data resources