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510(k) K811795

10% NEUTRAL BUFFERED FORMALDEHYDE by Richard-Allan Medical Ind., Inc. — Product Code IFP

K811795 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical Ind., Inc. for the device "10% NEUTRAL BUFFERED FORMALDEHYDE". The FDA issued a decision of Substantially Equivalent on July 28, 1981. The device falls under product code IFP (Formalin, Neutral Buffered), a Class I device regulated under 21 CFR 864.4010. Richard-Allan Medical Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1981
Date Received
June 24, 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 Richard-Allan Medical Ind., Inc.

  • K931879 — REFLEX HTR (March 24, 1994)
  • K924200 — REFLEX(R) ESC (February 22, 1994)
  • K926297 — REFLEX ESI (October 15, 1993)
  • K924761 — STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD (April 20, 1993)
  • K900566 — RICHARD-ALLAN VESSEL LOOPS (May 3, 1990)
  • K896262 — TITANIUM LIGATING CLIPS (January 2, 1990)
  • K890314 — PROTECTOR (SURGICAL INSTRUMENT) (February 27, 1989)
  • K873309 — REFLEX(TM) CA-T CLIP APPLIER (November 27, 1987)
  • K862404 — REFLEX(TM) CLIP APPLIER (July 23, 1986)
  • K862223 — MICRO THIN* PARAFFIN (June 17, 1986)

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