Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PROGESTERONE

K-Number: K790440 · 1979-05-03

ApplicantSerono Laboratories, Inc.
Decision Date1979-05-03
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROGESTERONE is the device name listed in this FDA 510(k) record. The listed applicant is Serono Laboratories, Inc.. It received FDA 510(k) clearance on 1979-05-03 under 510(k) number K790440. The device is classified under product code JLS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGESTERONE?

PROGESTERONE is a medical device that received FDA 510(k) clearance on 1979-05-03. The listed applicant is Serono Laboratories, Inc.. The 510(k) number is K790440.

When did PROGESTERONE receive FDA 510(k) clearance?

PROGESTERONE received FDA 510(k) clearance on 1979-05-03, under 510(k) number K790440.

Who is the listed applicant for PROGESTERONE?

The FDA 510(k) record lists Serono Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROGESTERONE?

The FDA product code for PROGESTERONE is JLS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Serono Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K834428ALDOSTERONE RADIOIMMUNOASSAY TEST KITK810695ESTRIOL RADIOIMMUNOASSAY TEST KITK810625HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-K792043PAP-CHECK RIA KITK790679ESTRADIOL RIA KITK782143RIA KIT, GLUCOSE

View all 10 devices →

Related Devices (Code: JLS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbHK973898PROGESTERONE ELISAKmi Diagnostics, Inc.K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)Johnson & Johnson Clinical Diagnostics, Inc.K971725OPUS PROGESTERONEBehring Diagnostics, Inc.K964841ELECSYS PROGESTERONE ASSAYBoehringer Mannheim Corp.K965084VIDAS PROESTERONE (PRG) (30 409)bioMerieux, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑