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)

LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E

K-Number: K944513 · 1994-12-02

ApplicantInternational Enzymes, Inc.
Decision Date1994-12-02
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E is the device name listed in this FDA 510(k) record. The listed applicant is International Enzymes, Inc.. It received FDA 510(k) clearance on 1994-12-02 under 510(k) number K944513. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E?

LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is International Enzymes, Inc.. The 510(k) number is K944513.

When did LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E receive FDA 510(k) clearance?

LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E received FDA 510(k) clearance on 1994-12-02, under 510(k) number K944513.

Who is the listed applicant for LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E?

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

What is the FDA product code for LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E?

The FDA product code for LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E is JJY.

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 International Enzymes, 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.

K011169HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3K963085LIQUID IMMUNOLOGY CONTROL LEVEL I, II, IIIK953926LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEMK953927LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEMK950802LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEMK944486LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E

View all 7 devices →

Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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.

↑