Home / 510(k) Clearances / K812940

510(k) K812940

10% NEUTRAL BUFFERED FORMALIN CONCENT by Surgipath — Product Code IFP

K812940 is an FDA 510(k) premarket notification submitted by Surgipath for the device "10% NEUTRAL BUFFERED FORMALIN CONCENT". The FDA issued a decision of Substantially Equivalent on December 10, 1981. The device falls under product code IFP (Formalin, Neutral Buffered), a Class I device regulated under 21 CFR 864.4010. Surgipath has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1981
Date Received
October 20, 1981
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 Surgipath

  • K820027 — MODIFIED EA 50 (February 4, 1982)
  • K812087 — EA 50 (August 13, 1981)
  • K812086 — EA 65 (August 13, 1981)
  • K811826 — EOSIN Y (July 10, 1981)
  • K811825 — ORANGE G-6 (July 10, 1981)
  • K810836 — DECALCIFIER II (April 23, 1981)
  • K810733 — HARRIS HEMATOXYLIN (April 14, 1981)
  • K810760 — GILL'S HEMATOXYLIN #3 (April 14, 1981)
  • K810758 — GILL'S HEMATOXYLIN #1 (April 14, 1981)
  • K810759 — GILL'S HEMATOXYLIN #2 (April 14, 1981)

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)
  • K842728 — BUF-FIX (August 3, 1984)
  • K840926 — FORMALIN SOLUTION 10% NEUTRAL BUFFER (March 12, 1984)
  • K830582 — MILLONIG'S MODIFIED PHOSPHATE BUFFERED (March 17, 1983)

FDA data resources