Harris Hematoxylin

FDA 510(k) K810733 · Surgipath

Substantially Equivalent

510(k) numberK810733

Submission

Device name
Harris Hematoxylin
Applicant
Surgipath
Mchenry, IL, US
Received
March 18, 1981
Decision date
April 14, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HYK – Hematoxylin Harris'S
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code HYK

510(k)DeviceApplicantDecision
K873107Instant HematoxylinHYK · Traditional Shandon, Inc.08/21/1987SE
K872498Harris HematoxylinHYK · Traditional Anatech, Ltd.07/09/1987SE
K843425Harris Hematoxylin, Mercury Free, AcidHYK · Traditional Accra Laboratories, Inc.10/02/1984SE
K823328Harris HematoxylinHYK · Traditional Accra Laboratories, Inc.12/28/1982SE
K800324Volu-Sol Harris HematoxylinHYK · Traditional Volu Sol Medical Industries02/22/1980SE
K781585Hematoxylin Stain HarrisHYK · Traditional Bioscientific10/10/1978SE

More from Bioscientific

510(k)DeviceDecision
K820027Modified Ea 50HZJ · Traditional 02/04/1982SE
K81294010% Neutral Buffered Formalin ConcentIFP · Traditional 12/10/1981SE
K812087Ea 50HZJ · Traditional 08/13/1981SE
K812086Ea 65HZJ · Traditional 08/13/1981SE
K811826Eosin YHYB · Traditional 07/10/1981SE
K811825Orange G-6HZH · Traditional 07/10/1981SE
K810836Decalcifier IIKDX · Traditional 04/23/1981SE
K810760Gill's Hematoxylin #3 · Traditional 04/14/1981SE
K810759Gill's Hematoxylin #2HYJ · Traditional 04/14/1981SE
K810758Gill's Hematoxylin #1HYJ · Traditional 04/14/1981SE

Questions and answers

When was Harris Hematoxylin cleared by the FDA?

Harris Hematoxylin (K810733) received a 510(k) decision of Substantially Equivalent on April 14, 1981, 27 days after the submission was received.

What is the product code of K810733?

The FDA product code is HYK – Hematoxylin Harris'S, a Class I (low risk) device regulated under 21 CFR 864.1850.