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FDA 510(k)

LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E

K-Number: K944486 · 1994-12-02

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

Device Summary

LINICAL PROTEIN I 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 K944486. 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 I CALIBRATION VERIFIERS LEVELS A - E?

LINICAL PROTEIN I 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 K944486.

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

LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E received FDA 510(k) clearance on 1994-12-02, under 510(k) number K944486.

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

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

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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 SYSTEMK944513LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E

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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.

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