Schiff Reagent

FDA 510(k) K883217 · Surgipath Medical Industries, Inc.

Substantially Equivalent

510(k) numberK883217

Submission

Device name
Schiff Reagent
Applicant
Surgipath Medical Industries, Inc.
Grayslake, IL, US
Received
July 29, 1988
Decision date
August 5, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HZT – Reagent, Schiff
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code HZT

510(k)DeviceApplicantDecision
K843752Sigma Periodic Acid-Schiff Stain 395HZT · Traditional Sigma Chemical Co.10/30/1984SE
K842919Schiff Reagent Fuchsin-Sulfurous AcidHZT · Traditional E K Ind., Inc.09/11/1984SE
K842917Schiff Reagent, Pas StainHZT · Traditional E K Ind., Inc.09/07/1984SE
K760031Histochemical Pas Reaction SetHZT · Traditional Harleco07/20/1976SE

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K863549Reusable/Disposable Autopsy Knife SetEMF · Traditional 09/30/1986SE
K863616Knife MakerIDL · Traditional 09/25/1986SE
K863548Rotary MicrotomeIDO · Traditional 09/19/1986SE
K863483Cassette EmbosseerIDZ · Traditional 09/16/1986SE
K863145Cervical ScrapersHHT · Traditional 08/19/1986SE
K861270Blue Ribbon Paraffin Infiltration/Embedding Med.KEO · Traditional 04/11/1986SE
K861201Formaldehyde Solution, 37%IGG · Traditional 04/11/1986SE

Questions and answers

When was Schiff Reagent cleared by the FDA?

Schiff Reagent (K883217) received a 510(k) decision of Substantially Equivalent on August 5, 1988, 7 days after the submission was received.

What is the product code of K883217?

The FDA product code is HZT – Reagent, Schiff, a Class I (low risk) device regulated under 21 CFR 864.1850.