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510(k) K841488

DECALCIFIER I by Surgipath Medical Industries, Inc. — Product Code KDX

K841488 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "DECALCIFIER I". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code KDX (Solution, Decalcifier, Acid Containing), 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
May 2, 1984
Date Received
April 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Decalcifier, Acid Containing
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 KDX

  • K872625 — DECALCIFYING SOLUTION (August 6, 1987)
  • K850636 — SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E (March 20, 1985)
  • K842726 — DECALCIFIER SOLUTION (August 3, 1984)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 1982)
  • K821443 — FORMICAL (June 2, 1982)
  • K811801 — CAL-RITE (July 28, 1981)
  • K810836 — DECALCIFIER II (April 23, 1981)

FDA data resources