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FDA 510(k)

VIGIL SEROLOGY CONTROL LEVEL C

K-Number: K010358 · 2001-03-05

ApplicantBeckman Coulter, Inc.
Decision Date2001-03-05
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIGIL SEROLOGY CONTROL LEVEL C is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2001-03-05 under 510(k) number K010358. 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 VIGIL SEROLOGY CONTROL LEVEL C?

VIGIL SEROLOGY CONTROL LEVEL C is a medical device that received FDA 510(k) clearance on 2001-03-05. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K010358.

When did VIGIL SEROLOGY CONTROL LEVEL C receive FDA 510(k) clearance?

VIGIL SEROLOGY CONTROL LEVEL C received FDA 510(k) clearance on 2001-03-05, under 510(k) number K010358.

Who is the listed applicant for VIGIL SEROLOGY CONTROL LEVEL C?

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

What is the FDA product code for VIGIL SEROLOGY CONTROL LEVEL C?

The FDA product code for VIGIL SEROLOGY CONTROL LEVEL C is JJY.

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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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