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FDA 510(k)

SPECIALTY ASSAYED CONTROL-2

K-Number: K100103 · 2010-12-15

ApplicantHelena Laboratories
Decision Date2010-12-15
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPECIALTY ASSAYED CONTROL-2 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 2010-12-15 under 510(k) number K100103. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECIALTY ASSAYED CONTROL-2?

SPECIALTY ASSAYED CONTROL-2 is a medical device that received FDA 510(k) clearance on 2010-12-15. The listed applicant is Helena Laboratories. The 510(k) number is K100103.

When did SPECIALTY ASSAYED CONTROL-2 receive FDA 510(k) clearance?

SPECIALTY ASSAYED CONTROL-2 received FDA 510(k) clearance on 2010-12-15, under 510(k) number K100103.

Who is the listed applicant for SPECIALTY ASSAYED CONTROL-2?

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

What is the FDA product code for SPECIALTY ASSAYED CONTROL-2?

The FDA product code for SPECIALTY ASSAYED CONTROL-2 is GGC.

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Related Devices (Code: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, Inc.K020878LYPHOCHEK HEMOSTASIS, MODELS 798, 799Bio-Rad

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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