Prolactin System by Ria

FDA 510(k) K851330 · American Bioclinical, Inc.

Substantially Equivalent

510(k) numberK851330

Submission

Device name
Prolactin System by Ria
Applicant
American Bioclinical, Inc.
Portland, OR, US
Received
April 4, 1985
Decision date
April 29, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CFT – Radioimmunoassay, Prolactin (Lactogen)
Device class
Class I (low risk)
Regulation
21 CFR 862.1625
Specialty
Clinical Chemistry

Other 510(k)s with product code CFT

510(k)DeviceApplicantDecision
K971921Prolactin (PRL) Hormone Microplate ElisaCFT · Traditional Monobind06/24/1997SE
K970281Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsCFT · Traditional Johnson & Johnson Clinical Diagnostics, Inc.02/25/1997SE
K970188Sealite Sciences, Inc. Aqualite ProlactinCFT · Traditional Sealite Sciences, Inc.02/20/1997SE
K964748Elecsys Prolactin AssayCFT · Traditional Boehringer Mannheim Corp.01/21/1997SE
K960561DSL Active Prolactin Elisa Model 10-4500CFT · Traditional Diagnostic Systems Laboratories, Inc.04/26/1996SE
K960060DSL Active Prolactin IrmaCFT · Traditional Diagnostic Systems Laboratories, Inc.02/29/1996SE
K954680Access Prolactin Assay (Modification)CFT · Traditional Bio-Rad Laboratories, Inc.10/20/1995SE
K953656Abbott Imx Prolactin(Modification)CFT · Traditional Abbott Mfg., Inc.10/03/1995SE
K953657Abbott Axsym Prolactin(Modification)CFT · Traditional Abbott Mfg., Inc.09/25/1995SE
K944698Auraflex Prolactin 200 Test Pack, Calibrator Pack, Dilvent 1CFT · Traditional Organon Teknika Corp.03/21/1995SE

More from Organon Teknika Corp.

510(k)DeviceDecision
K852939Cortisol System by EiaCGR · Traditional 08/02/1985SE
K852437Visual Serum/Urine HCG Combo KitJHI · Traditional 07/12/1985SE
K852376Simultaneous Lh/Fsh System by RiaCEP · Traditional 07/09/1985SE

Questions and answers

When was Prolactin System by Ria cleared by the FDA?

Prolactin System by Ria (K851330) received a 510(k) decision of Substantially Equivalent on April 29, 1985, 25 days after the submission was received.

What is the product code of K851330?

The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.