Neia Pap Enzymeimmunoassay

FDA 510(k) K811757 · New England Immunology Assoc.

Substantially Equivalent

510(k) numberK811757

Submission

Device name
Neia Pap Enzymeimmunoassay
Applicant
New England Immunology Assoc.
Mchenry, IL, US
Received
June 22, 1981
Decision date
August 13, 1981
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
K813288Neia Transferrin EnzymeimmunoassayDDG · Traditional 12/17/1981SE
K790490Neia-Ferritin Enzymeimmunassay KitDBF · Traditional 04/23/1979SE
K780490Neia-Ferritin EnzymeimmunoassayDBF · Traditional 04/10/1978SE

Questions and answers

When was Neia Pap Enzymeimmunoassay cleared by the FDA?

Neia Pap Enzymeimmunoassay (K811757) received a 510(k) decision of Substantially Equivalent on August 13, 1981, 52 days after the submission was received.

What is the product code of K811757?

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