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)

SERATEST ENA [SCL-70] KIT

K-Number: K894411 · 1989-08-02

ApplicantHemagen Diagnostics, Inc.
Decision Date1989-08-02
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERATEST ENA [SCL-70] KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-08-02 under 510(k) number K894411. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERATEST ENA [SCL-70] KIT?

SERATEST ENA [SCL-70] KIT is a medical device that received FDA 510(k) clearance on 1989-08-02. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K894411.

When did SERATEST ENA [SCL-70] KIT receive FDA 510(k) clearance?

SERATEST ENA [SCL-70] KIT received FDA 510(k) clearance on 1989-08-02, under 510(k) number K894411.

Who is the listed applicant for SERATEST ENA [SCL-70] KIT?

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

What is the FDA product code for SERATEST ENA [SCL-70] KIT?

The FDA product code for SERATEST ENA [SCL-70] KIT is LKJ.

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 Hemagen Diagnostics, 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.

K041051RAICHEM BUN RATE REAGENT (LIQUID)K041052RAICHEM GLUCOSE UV (LIQUID)K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTK031101RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2K023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERK022772RAICHEM LDL-CHOLESTEROL DIRECT REAGENT

View all 52 devices →

Related Devices (Code: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K081104AESKULISA ANA HEP-2, REF 30-7115USAesku DiagnosticsK041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, 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.

↑