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510(k) K853497

PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN by Surgipath Medical Industries, Inc. — Product Code IFP

K853497 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN". The FDA issued a decision of Substantially Equivalent on August 28, 1985. The device falls under product code IFP (Formalin, Neutral Buffered), a Class I device regulated under 21 CFR 864.4010. Surgipath Medical Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1985
Date Received
August 20, 1985
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 Medical Industries, Inc.

  • K883217 — SCHIFF REAGENT (August 5, 1988)
  • K881921 — C-E BRUSH (July 19, 1988)
  • K881922 — CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (May 25, 1988)
  • K881659 — TISSUE SECTION ADHESIVE (April 21, 1988)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K863616 — KNIFE MAKER (September 25, 1986)
  • K863548 — ROTARY MICROTOME (September 19, 1986)
  • K863483 — CASSETTE EMBOSSEER (September 16, 1986)
  • K863145 — CERVICAL SCRAPERS (August 19, 1986)
  • K861201 — FORMALDEHYDE SOLUTION, 37% (April 11, 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)
  • 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