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FDA 510(k)

IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3

K-Number: K020237 · 2002-03-19

ApplicantConsolidated Technology
Decision Date2002-03-19
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Technology. It received FDA 510(k) clearance on 2002-03-19 under 510(k) number K020237. 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 IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3?

IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 is a medical device that received FDA 510(k) clearance on 2002-03-19. The listed applicant is Consolidated Technology. The 510(k) number is K020237.

When did IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 receive FDA 510(k) clearance?

IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 received FDA 510(k) clearance on 2002-03-19, under 510(k) number K020237.

Who is the listed applicant for IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3?

The FDA 510(k) record lists Consolidated Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3?

The FDA product code for IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 is JJY.

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Other records listing Consolidated Technology 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.

K033344LIGAND PLUS CONTROL LEVEL 1-3K023731QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3K003716CONFORMANCE CHEMISTRY CONTROL C3

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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