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FDA 510(k)

COLOR-SLIDE RF

K-Number: K981496 · 1998-06-15

ApplicantSeradyn, Inc.
Decision Date1998-06-15
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COLOR-SLIDE RF is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 1998-06-15 under 510(k) number K981496. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLOR-SLIDE RF?

COLOR-SLIDE RF is a medical device that received FDA 510(k) clearance on 1998-06-15. The listed applicant is Seradyn, Inc.. The 510(k) number is K981496.

When did COLOR-SLIDE RF receive FDA 510(k) clearance?

COLOR-SLIDE RF received FDA 510(k) clearance on 1998-06-15, under 510(k) number K981496.

Who is the listed applicant for COLOR-SLIDE RF?

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

What is the FDA product code for COLOR-SLIDE RF?

The FDA product code for COLOR-SLIDE RF is DHR.

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Other records listing Seradyn, 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.

K070645SERADYN QMS TOPIRAMATEK062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSK062204ARCHITECT CORTISOL ASSAYK060998QMS TOBRAMYCINK060709MULTIGENT GENTAMICINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

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Related Devices (Code: DHR)

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.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical CompanyK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, Inc.

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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