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FDA 510(k)

RA 80 EIKEN

K-Number: K854820 · 1986-01-17

ApplicantSyn-Kit, Inc.
Decision Date1986-01-17
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RA 80 EIKEN is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1986-01-17 under 510(k) number K854820. 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 RA 80 EIKEN?

RA 80 EIKEN is a medical device that received FDA 510(k) clearance on 1986-01-17. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K854820.

When did RA 80 EIKEN receive FDA 510(k) clearance?

RA 80 EIKEN received FDA 510(k) clearance on 1986-01-17, under 510(k) number K854820.

Who is the listed applicant for RA 80 EIKEN?

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

What is the FDA product code for RA 80 EIKEN?

The FDA product code for RA 80 EIKEN is DHR.

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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 Syn-Kit, 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK853276ASO SLIDE EIKENK843758UROPAPER EIKEN GKK843753UROPAPER EIKEN GP

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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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