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510(k) K852045

SED-FIX CONCENTRATE by Surgipath Medical Industries, Inc. — Product Code IER

K852045 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "SED-FIX CONCENTRATE". The FDA issued a decision of Substantially Equivalent on June 10, 1985. The device falls under product code IER (Polyethylene Glycol (Carbowax)), 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
June 10, 1985
Date Received
May 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polyethylene Glycol (Carbowax)
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)

FDA data resources