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)

BIOCLONES ELEGANCE LH ELISA KIT

K-Number: K904387 · 1990-11-06

ApplicantBioclone Australia Pty , Ltd.
Decision Date1990-11-06
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOCLONES ELEGANCE LH ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioclone Australia Pty , Ltd.. It received FDA 510(k) clearance on 1990-11-06 under 510(k) number K904387. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCLONES ELEGANCE LH ELISA KIT?

BIOCLONES ELEGANCE LH ELISA KIT is a medical device that received FDA 510(k) clearance on 1990-11-06. The listed applicant is Bioclone Australia Pty , Ltd.. The 510(k) number is K904387.

When did BIOCLONES ELEGANCE LH ELISA KIT receive FDA 510(k) clearance?

BIOCLONES ELEGANCE LH ELISA KIT received FDA 510(k) clearance on 1990-11-06, under 510(k) number K904387.

Who is the listed applicant for BIOCLONES ELEGANCE LH ELISA KIT?

The FDA 510(k) record lists Bioclone Australia Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCLONES ELEGANCE LH ELISA KIT?

The FDA product code for BIOCLONES ELEGANCE LH ELISA KIT is CEP.

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 Bioclone Australia Pty , Ltd. 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.

K935049ELEGANCE NEONATAL TSH ELISAK922284ELEGANCE FT4 ELISAK910419BIOCLONE'S ELEGANCE IGE ELISA KITK910420BIOCLONE'S ELEGANCE HCG ELISA KITK905099ELEGANCE TSH ELISAK905098ELEGANCE GH ELISA

View all 10 devices →

Related Devices (Code: CEP)

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.

K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?MomK022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, 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.

↑