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)

IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS

K-Number: K864409 · 1986-12-22

ApplicantSclavo, Inc.
Decision Date1986-12-22
Product CodeLER
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1986-12-22 under 510(k) number K864409. The device is classified under product code LER. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS?

IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Sclavo, Inc.. The 510(k) number is K864409.

When did IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS receive FDA 510(k) clearance?

IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS received FDA 510(k) clearance on 1986-12-22, under 510(k) number K864409.

Who is the listed applicant for IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS?

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

What is the FDA product code for IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS?

The FDA product code for IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS is LER.

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 Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

View all 82 devices →

Related Devices (Code: LER)

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.

K942192THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K905521CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATIONMicrogenics Corp.K882570TURBOX THEOPHYLLINE ASSAYUnipath , Ltd.K863475THEOFAST(TM) TEST PACKAGE3M CompanyK842585THEOPHYLLINE KIT FLUORESCENCE POLARIZA-Windsor Laboratories, Inc.K840758IMMPULSE THEOPHYLLINE ASSAY REAGENTSParagon Diagnostics, 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.

↑