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FDA 510(k)

QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3

K-Number: K992939 · 1999-12-09

ApplicantSeracare Technology
Decision Date1999-12-09
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 is the device name listed in this FDA 510(k) record. The listed applicant is Seracare Technology. It received FDA 510(k) clearance on 1999-12-09 under 510(k) number K992939. 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 QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3?

QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 is a medical device that received FDA 510(k) clearance on 1999-12-09. The listed applicant is Seracare Technology. The 510(k) number is K992939.

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

QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 received FDA 510(k) clearance on 1999-12-09, under 510(k) number K992939.

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

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

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

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

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Other records listing Seracare 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.

K993631QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2K993715QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3K992770QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3K992395URINE DRUG SCREENING CONTROL

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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