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 PHENYTOIN ASSAY REAGENT

K-Number: K862554 · 1986-07-16

ApplicantSclavo, Inc.
Decision Date1986-07-16
Product CodeLGR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMPULSE PHENYTOIN ASSAY REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1986-07-16 under 510(k) number K862554. The device is classified under product code LGR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMPULSE PHENYTOIN ASSAY REAGENT?

IMMPULSE PHENYTOIN ASSAY REAGENT is a medical device that received FDA 510(k) clearance on 1986-07-16. The listed applicant is Sclavo, Inc.. The 510(k) number is K862554.

When did IMMPULSE PHENYTOIN ASSAY REAGENT receive FDA 510(k) clearance?

IMMPULSE PHENYTOIN ASSAY REAGENT received FDA 510(k) clearance on 1986-07-16, under 510(k) number K862554.

Who is the listed applicant for IMMPULSE PHENYTOIN ASSAY REAGENT?

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 PHENYTOIN ASSAY REAGENT?

The FDA product code for IMMPULSE PHENYTOIN ASSAY REAGENT is LGR.

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: LGR)

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.

K955873ACS PHENYTOIN ASSAYCiba Corning Diagnostics Corp.K955562INNOFLUOR PHENYTOIN ASSAY SYSTEMOxis Intl., Inc.K953840AXSYM PHENYTOIN IIAbbott LaboratoriesK946328TDX(R)/TDXFLX(R) PHENYTOIN IIAbbott LaboratoriesK943313PHENYTOIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K935375AXSYM PHENYTOIN ASSAYAbbott Laboratories

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.

↑