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 KIT BY RIA

K-Number: K813484 · 1981-12-22

ApplicantImmuchem Corp.
Decision Date1981-12-22
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROGESTERONE KIT BY RIA is the device name listed in this FDA 510(k) record. The listed applicant is Immuchem Corp.. It received FDA 510(k) clearance on 1981-12-22 under 510(k) number K813484. 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 KIT BY RIA?

PROGESTERONE KIT BY RIA is a medical device that received FDA 510(k) clearance on 1981-12-22. The listed applicant is Immuchem Corp.. The 510(k) number is K813484.

When did PROGESTERONE KIT BY RIA receive FDA 510(k) clearance?

PROGESTERONE KIT BY RIA received FDA 510(k) clearance on 1981-12-22, under 510(k) number K813484.

Who is the listed applicant for PROGESTERONE KIT BY RIA?

The FDA 510(k) record lists Immuchem Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROGESTERONE KIT BY RIA?

The FDA product code for PROGESTERONE KIT BY RIA 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 Immuchem Corp. 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.

K883726THYROID STIMULATING HORMONE (HTSH) IRMA NEONATALK871317FOLLICLE STIMULATING HORMONE (HFSH)K871542HPROLACTIN KITK865071THYROID STIMULATING HORMONE (TSH IRMA) RIA KITK864144LUTEINIZING HORMONE (LH-IRMA) RIA KITK860559ANDROSTENEDIONE 125I KIT BY RIA

View all 18 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.

↑