Microscope Slides Precoated W/Histogrip & Poly-Ly

FDA 510(k) K882357 · Stat Path

Substantially Equivalent

510(k) numberK882357

Submission

Device name
Microscope Slides Precoated W/Histogrip & Poly-Ly
Applicant
Stat Path
Riderwood, MD, US
Received
June 7, 1988
Decision date
June 16, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KEW – Slides, Microscope
Device class
Class I (low risk)
Regulation
21 CFR 864.3010
Specialty
Pathology

Other 510(k)s with product code KEW

510(k)DeviceApplicantDecision
K891604The Cen-Slide(Tm) Centrifuge TubeKEW · Traditional Davstar California, Inc.06/16/1989SE
K890042Microscope Slides PrecoatedKEW · Traditional Stat Path01/13/1989SE
K831065Sectioning Aid KitKEW · Traditional Technicon Instruments Corp.06/08/1983SE
K820100Frosted Glass SlidesKEW · Traditional Stan-Pak Ent.03/04/1982SE
K813242Quantimetric 2 Test KitKEW · Traditional Kallestad Laboratories, Inc.12/02/1981SE
K800232Abco Ultra Slide Microscope SlideKEW · Traditional Abco Dealers, Inc.02/21/1980SE
K760278Slide, Lab-Tek Covered MicroKEW · Traditional Miles Laboratories, Inc.08/30/1976SE

More from Miles Laboratories, Inc.

510(k)DeviceDecision
K890042Microscope Slides PrecoatedKEW · Traditional 01/13/1989SE
K882362Stat Fix Microwave Irradiation MediumLDJ · Traditional 06/22/1988SE
K881477Histogrip & Histogrip Gold Concentrate/PredilutedKEL · Traditional 04/18/1988SE

Questions and answers

When was Microscope Slides Precoated W/Histogrip & Poly-Ly cleared by the FDA?

Microscope Slides Precoated W/Histogrip & Poly-Ly (K882357) received a 510(k) decision of Substantially Equivalent on June 16, 1988, 9 days after the submission was received.

What is the product code of K882357?

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