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510(k) K830515

SCOTTS TAP WATER SUBSTITUTE CONCENTRATE by Surgipath Medical Industries, Inc. — Product Code KEQ

K830515 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "SCOTTS TAP WATER SUBSTITUTE CONCENTRATE". The FDA issued a decision of Substantially Equivalent on March 31, 1983. The device falls under product code KEQ (Media, Mounting, Water Soluble), 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
March 31, 1983
Date Received
February 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Mounting, Water Soluble
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 KEQ

  • K792709 — KOH MOUNTING FLUID W/GLYCEROL (January 24, 1980)
  • K792703 — LACTO-PHENOL ANALINE BLUE FLUID (January 24, 1980)
  • K792702 — VASPAR SEALANT (January 24, 1980)
  • K781868 — DROPPER, CEPTI-SEAL LAVTOPHENOL (November 22, 1978)
  • K781869 — DROPPER, CEPTI-SEAL KOH SOLUTION (November 22, 1978)
  • K781388 — F.A. MOUNTING MEDIUM (August 21, 1978)

FDA data resources