Instant Eosin-Aqueous

FDA 510(k) K893663 · Shandon, Inc.

Substantially Equivalent

510(k) numberK893663

Submission

Device name
Instant Eosin-Aqueous
Applicant
Shandon, Inc.
Pittsburgh, PA, US
Received
May 15, 1989
Decision date
June 13, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HYB – Eosin Y
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code HYB

510(k)DeviceApplicantDecision
K880596Eosin Y Solution, Alcoholic, with PhloxineHYB · Traditional Sigma Chemical Co.03/31/1988SE
K880240Instant Eosin-AlcoholicHYB · Traditional Shandon, Inc.03/03/1988SE
K843426Eosin Y 1% AlcoholicHYB · Traditional Accra Laboratories, Inc.09/27/1984SE
K822982Midas 100 Hemacolor Stain #66030HYB · Traditional Emd Chemicals, Inc.10/27/1982SE
K821574Eosin Y Solutin, AgueousHYB · Traditional Sigma Chemical Co.06/10/1982SE
K821573Eosin Y Solution AlcholicHYB · Traditional Sigma Chemical Co.06/09/1982SE
K811797Eosin-YHYB · Traditional Richard-Allan Medical Ind., Inc.07/28/1981SE
K811826Eosin YHYB · Traditional Surgipath07/10/1981SE
K800942Volu-Sol Eosin Y StainHYB · Traditional Volu Sol Medical Industries05/08/1980SE

More from Volu Sol Medical Industries

510(k)DeviceDecision
K890984Linistain SLSKIO · Traditional 04/04/1989SE
K880240Instant Eosin-AlcoholicHYB · Traditional 03/03/1988SE
K873107Instant HematoxylinHYK · Traditional 08/21/1987SE
K780261CoverslipperKIM · Traditional 04/18/1978SE

Questions and answers

When was Instant Eosin-Aqueous cleared by the FDA?

Instant Eosin-Aqueous (K893663) received a 510(k) decision of Substantially Equivalent on June 13, 1989, 29 days after the submission was received.

What is the product code of K893663?

The FDA product code is HYB – Eosin Y, a Class I (low risk) device regulated under 21 CFR 864.1850.