Dispette II

FDA 510(k) K860899 · Ulster Scientific, Inc.

Substantially Equivalent

510(k) numberK860899

Submission

Device name
Dispette II
Applicant
Ulster Scientific, Inc.
Highland, NY, US
Received
March 10, 1986
Decision date
April 14, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JPH – Test, Erythrocyte Sedimentation Rate
Device class
Class I (low risk)
Regulation
21 CFR 864.6700
Specialty
Hematology

Other 510(k)s with product code JPH

510(k)DeviceApplicantDecision
K871076WinpetteJPH · Traditional Ulster Scientific, Inc.03/23/1987SE
K852554Srt-SystemJPH · Traditional Microwave Development, Inc.07/18/1985SE
K840500SediplastJPH · Traditional Precision Technology, Inc.02/21/1984SE
K831195Westergren Dispette for EsrJPH · Traditional Ulster Scientific, Inc.05/09/1983SE
K823761Erythrocyte & Stand Sediment. Rate TubeJPH · Traditional Cordis Corp.01/21/1983SE
K823368Dade Esr KitJPH · Traditional American Dade12/28/1982SE

More from American Dade

510(k)DeviceDecision
K942620Feather-Touch Single-Stick DeviceFMK · Traditional 06/22/1994SE
K920562UnistikFMK · Traditional 03/27/1992SE
K902592Epc Electronic Pipetting SystemJQW · Traditional 07/19/1990SE
K895890AutopenFMF · Traditional 02/16/1990SE
K894474The Autolet LiteFMK · Traditional 08/18/1989SE
K885340Air Displacement PipetteJQW · Traditional 02/14/1989SE
K875354Unistep Capillary Blood Collection SystemLCP · Traditional 02/17/1988SE
K871571Neurotips(Tm)GXB · Traditional 06/18/1987SE
K871076WinpetteJPH · Traditional 03/23/1987SE
K870078Accupen(R)FMF · Traditional 03/17/1987SE

Questions and answers

When was Dispette II cleared by the FDA?

Dispette II (K860899) received a 510(k) decision of Substantially Equivalent on April 14, 1986, 35 days after the submission was received.

What is the product code of K860899?

The FDA product code is JPH – Test, Erythrocyte Sedimentation Rate, a Class I (low risk) device regulated under 21 CFR 864.6700.