Enzyme Immunoassay for the Detection of Salivary 17-A-HYDROXYPROGESTERONE

FDA 510(k) K062534 · Drg Intl., Inc.

Substantially Equivalent

510(k) numberK062534

Submission

Device name
Enzyme Immunoassay for the Detection of Salivary 17-A-HYDROXYPROGESTERONE
Applicant
Drg Intl., Inc.
East Stroudsburg, PA, US
Received
August 29, 2006
Decision date
January 29, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JLX – Radioimmunoassay, 17-Hydroxyprogesterone
Device class
Class I (low risk)
Regulation
21 CFR 862.1395
Specialty
Clinical Chemistry

Other 510(k)s with product code JLX

510(k)DeviceApplicantDecision
K100682GSP Neonatal 17A-OH-PROGESTERONE Kit Model: 3305-001UJLX · Traditional Wallac OY07/23/2010SE
K081922Autodelfia Neonatal 17A-OH-PROGESTERONE KitJLX · Traditional Wallac OY04/16/2009SE
K060452Accuwell 17-ALPHA-HYDROXYPROESTERONE Enzyme Immunoassay with Models 6015XX-ECAHJLX · Abbreviated Neo-Genesis03/13/2007SE
K050960Modification to: Autodelfia Neonatal 17A-OH-PROGESTERONE L KitJLX · Special Wallac OY07/11/2005SE
K042425Autodelfia Neonatal 17A-OH-PROGESTERONE KitJLX · Special Wallac OY09/30/2004SE
K042424Delfia Neonatal 17A-OH-PROGESTERONE KitJLX · Special Wallac OY09/30/2004SE
K973350Bio-Rad Microplate 17-HYDROXYPROGESTERONE TestJLX · Traditional Bio-Rad02/09/1998SE
K934178Accuscreen 17-HYDROXYPROGESTERONEJLX · Traditional Neometrics, Inc.03/30/1995SE
K940233Neoscreen Elisa HydroxyprogesteroneJLX · Traditional Pantex12/28/1994SE
K943148DSL Active 17A-OH Progesterone Ria (DSL 5000)JLX · Traditional Diagnostic Systems Laboratories, Inc.11/10/1994SE

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510(k)DeviceDecision
K052649DRG SLV Testosterone Elisa TestCDZ · Traditional 01/27/2006SE
K051733Enzyme Immunoassay for the Detection of Salivary CortisolNHG · Traditional 12/07/2005SE
K000043DRG Aurica Elisa Testosterone KitCDZ · Traditional 04/17/2000SE

Questions and answers

When was Enzyme Immunoassay for the Detection of Salivary 17-A-HYDROXYPROGESTERONE cleared by the FDA?

Enzyme Immunoassay for the Detection of Salivary 17-A-HYDROXYPROGESTERONE (K062534) received a 510(k) decision of Substantially Equivalent on January 29, 2008, 518 days after the submission was received.

What is the product code of K062534?

The FDA product code is JLX – Radioimmunoassay, 17-Hydroxyprogesterone, a Class I (low risk) device regulated under 21 CFR 862.1395.