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FDA 510(k)

QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2

K-Number: K961293 · 1996-05-02

ApplicantConsolidated Technologies, Inc.
Decision Date1996-05-02
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Technologies, Inc.. It received FDA 510(k) clearance on 1996-05-02 under 510(k) number K961293. 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 QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2?

QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 is a medical device that received FDA 510(k) clearance on 1996-05-02. The listed applicant is Consolidated Technologies, Inc.. The 510(k) number is K961293.

When did QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 receive FDA 510(k) clearance?

QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 received FDA 510(k) clearance on 1996-05-02, under 510(k) number K961293.

Who is the listed applicant for QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2?

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

What is the FDA product code for QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2?

The FDA product code for QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 is JJY.

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Other records listing Consolidated Technologies, 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.

K000116QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3K992578URINE CHEMISTRY CONTROL, LEVEL 2K992576URINE CHEMISTRY CONTROL, LEVEL 1K992151REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINEK981339QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3K974699REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE

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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

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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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