Ria Kit, Prostatic Acid

FDA 510(k) K790580 · Monitor Science Corp.

Substantially Equivalent

510(k) numberK790580

Submission

Device name
Ria Kit, Prostatic Acid
Applicant
Monitor Science Corp.
Mchenry, IL, US
Received
March 27, 1979
Decision date
May 25, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JFH – Acid Phosphatase (Prostatic), Tartrate Inhibited
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1020
Specialty
Clinical Chemistry

Other 510(k)s with product code JFH

510(k)DeviceApplicantDecision
K000257Immulite 2000 Pap, Models L2KPA2, L2KPA6JFH · Traditional Diagnostic Products Corp.02/23/2000SE
K981573Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia QuantitatveJFH · Traditional United Biotech, Inc.09/15/1998SE
K964756Prostatic Acid Phosphatase Reagent Test/Prostatic Acid Phosphatase Reagent KitJFH · Traditional Wano-Tech Corp.04/23/1997SE
K931701Immulite PapJFH · Traditional Diagnostic Products Corp.01/27/1994SE
K925377Imx PapJFH · Traditional Abbott Laboratories01/13/1993SE
K921745Hybritech Stratus Pap Fluorometric Enzyme ImmunoJFH · Traditional Hybritech, Inc.07/30/1992SE
K902937Milenia Pap Irma Catalog #: MKPA1, XJFH · Traditional Diagnostic Products Corp.09/21/1990SE
K901933Coat-A-Count Pap Irma, Catlog# 1KPA1, 1KPA2JFH · Traditional Diagnostic Products Corp.06/28/1990SE
K895723Irma-Count(Tm) Pap, (RKPA1, RKPA2)JFH · Traditional Diagnostic Products Corp.10/31/1989SE
K893508Prostate Specific Antigen Immunohistochemical AntiJFH · Traditional Baxter Healthcare Corp08/04/1989SE

More from Baxter Healthcare Corp

510(k)DeviceDecision
K780951Bio-Monitor GentamicinDKD · Traditional 08/14/1978SE
K780950Bio-Monitor TobramycinDID · Traditional 08/14/1978SE
K780949Bio-Monitor AmikacinKLP · Traditional 08/14/1978SE
K772038Kanamycin RiaKJI · Traditional 01/12/1978SE
K772039Beta-Hcg RiaJHI · Traditional 11/23/1977SE

Questions and answers

When was Ria Kit, Prostatic Acid cleared by the FDA?

Ria Kit, Prostatic Acid (K790580) received a 510(k) decision of Substantially Equivalent on May 25, 1979, 59 days after the submission was received.

What is the product code of K790580?

The FDA product code is JFH – Acid Phosphatase (Prostatic), Tartrate Inhibited, a Class II (moderate risk) device regulated under 21 CFR 862.1020.