Krystalonr Liq. Mounting Med.&Coverslip

FDA 510(k) K771925 · Harleco

Substantially Equivalent

510(k) numberK771925

Submission

Device name
Krystalonr Liq. Mounting Med.&Coverslip
Applicant
Harleco
Mchenry, IL, US
Received
October 14, 1977
Decision date
November 2, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KES – Coverslips, Microscope Slide
Device class
Class I (low risk)
Regulation
21 CFR 864.3010
Specialty
Pathology

Other 510(k)s with product code KES

510(k)DeviceApplicantDecision
K882881Sakura-Medscand SCA-1800 Automatic CoverslipperKES · Traditional Sakura Finetek U.S.A., Inc.07/28/1988SE
K872874Microscope Cover GlassesKES · Traditional Abco Dealers, Inc.08/10/1987SE

More from Abco Dealers, Inc.

510(k)DeviceDecision
K820233Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional 02/12/1982SE
K813427Ultrachem Gluc-DhLFR · Traditional 12/31/1981SE
K813044Ultrachem Alb, Item #64970CIX · Traditional 11/10/1981SE
K813043Ultrachem Crea Item #64972CGX · Traditional 11/10/1981SE
K813042Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional 11/10/1981SE
K813041Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional 11/10/1981SE
K813040Ultrachem Ca, Item #64975CJY · Traditional 11/10/1981SE
K813039Ultrachem E-Chol, Item #65025CHH · Traditional 11/10/1981SE
K813038Ultrachem TP, Item #64974CEK · Traditional 11/10/1981SE
K812594Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional 10/02/1981SE

Questions and answers

When was Krystalonr Liq. Mounting Med.&Coverslip cleared by the FDA?

Krystalonr Liq. Mounting Med.&Coverslip (K771925) received a 510(k) decision of Substantially Equivalent on November 2, 1977, 19 days after the submission was received.

What is the product code of K771925?

The FDA product code is KES – Coverslips, Microscope Slide, a Class I (low risk) device regulated under 21 CFR 864.3010.