Schiff Reagent Fuchsin-Sulfurous Acid

FDA 510(k) K842919 · E K Ind., Inc.

Substantially Equivalent

510(k) numberK842919

Submission

Device name
Schiff Reagent Fuchsin-Sulfurous Acid
Applicant
E K Ind., Inc.
Walker, MI, US
Received
July 25, 1984
Decision date
September 11, 1984
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
K883217Schiff ReagentHZT · Traditional Surgipath Medical Industries, Inc.08/05/1988SE
K843752Sigma Periodic Acid-Schiff Stain 395HZT · Traditional Sigma Chemical Co.10/30/1984SE
K842917Schiff Reagent, Pas StainHZT · Traditional E K Ind., Inc.09/07/1984SE
K760031Histochemical Pas Reaction SetHZT · Traditional Harleco07/20/1976SE

More from Harleco

510(k)DeviceDecision
K842931Drabkin ReagentKAG · Traditional 09/21/1984SE
K842938Acetic Acid 1% V/VGGK · Traditional 09/14/1984SE
K842937Acetic Acid 2% V/VGGK · Traditional 09/12/1984SE
K842936Acetic Acid, 3% V/VGGK · Traditional 09/12/1984SE
K842935Acetic Acid, 5% V/VGGK · Traditional 09/12/1984SE
K842934Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional 09/12/1984SE
K842933Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional 09/11/1984SE
K842930Gomori's Trichrome StainLED · Traditional 09/11/1984SE
K842928Jenner Blood StainKJX · Traditional 09/11/1984SE
K842927Light Green SF 1%HYS · Traditional 09/11/1984SE

Questions and answers

When was Schiff Reagent Fuchsin-Sulfurous Acid cleared by the FDA?

Schiff Reagent Fuchsin-Sulfurous Acid (K842919) received a 510(k) decision of Substantially Equivalent on September 11, 1984, 48 days after the submission was received.

What is the product code of K842919?

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