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)

ABC FP ANALYZER

K-Number: K883533 · 1988-12-15

ApplicantIntl. Bioclinical, Inc.
Decision Date1988-12-15
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABC FP ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Bioclinical, Inc.. It received FDA 510(k) clearance on 1988-12-15 under 510(k) number K883533. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABC FP ANALYZER?

ABC FP ANALYZER is a medical device that received FDA 510(k) clearance on 1988-12-15. The listed applicant is Intl. Bioclinical, Inc.. The 510(k) number is K883533.

When did ABC FP ANALYZER receive FDA 510(k) clearance?

ABC FP ANALYZER received FDA 510(k) clearance on 1988-12-15, under 510(k) number K883533.

Who is the listed applicant for ABC FP ANALYZER?

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

What is the FDA product code for ABC FP ANALYZER?

The FDA product code for ABC FP ANALYZER is JJE.

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 Intl. Bioclinical, 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.

K913187INNOFLUOR(TM) DIGITOXIN REAGENT SETK913186INNOFLUOR(TM) DIGITOXIN CALIBRATOR SETK911688INNOFLUOR(TM) VALPROIC ACID REAGENT SETK911466INNOFLUOR VALPROIC ACID CALIBRATOR SETK864156PROGESTERONE SYSTEM BY EIA

Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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.

↑