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510(k) K883217

SCHIFF REAGENT by Surgipath Medical Industries, Inc. — Product Code HZT

K883217 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "SCHIFF REAGENT". The FDA issued a decision of Substantially Equivalent on August 5, 1988. The device falls under product code HZT (Reagent, Schiff), a Class I device regulated under 21 CFR 864.1850. Surgipath Medical Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1988
Date Received
July 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Schiff
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Surgipath Medical Industries, Inc.

  • 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)
  • K861270 — BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. (April 11, 1986)

Other clearances for product code HZT

  • K843752 — SIGMA PERIODIC ACID-SCHIFF STAIN 395 (October 30, 1984)
  • K842919 — SCHIFF REAGENT FUCHSIN-SULFUROUS ACID (September 11, 1984)
  • K842917 — SCHIFF REAGENT, PAS STAIN (September 7, 1984)
  • K760031 — HISTOCHEMICAL PAS REACTION SET (July 20, 1976)

FDA data resources