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)

TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT

K-Number: K895094 · 1989-10-31

ApplicantHybritech, Inc.
Decision Date1989-10-31
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hybritech, Inc.. It received FDA 510(k) clearance on 1989-10-31 under 510(k) number K895094. 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 TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT?

TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Hybritech, Inc.. The 510(k) number is K895094.

When did TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT receive FDA 510(k) clearance?

TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT received FDA 510(k) clearance on 1989-10-31, under 510(k) number K895094.

Who is the listed applicant for TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT?

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

What is the FDA product code for TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT?

The FDA product code for TANDEM-E LH IMMUNOENZYMETRIC ASSAY 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 Hybritech, 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.

K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYK961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYK922754TANDEM-E IGE II CALIBRATION VERIFICATION SETK921745HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNOK921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

View all 63 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.

↑