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FDA 510(k)

RHEUMATELL

K-Number: K790351 · 1979-03-15

ApplicantCentral Biological Co.
Decision Date1979-03-15
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMATELL is the device name listed in this FDA 510(k) record. The listed applicant is Central Biological Co.. It received FDA 510(k) clearance on 1979-03-15 under 510(k) number K790351. 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 RHEUMATELL?

RHEUMATELL is a medical device that received FDA 510(k) clearance on 1979-03-15. The listed applicant is Central Biological Co.. The 510(k) number is K790351.

When did RHEUMATELL receive FDA 510(k) clearance?

RHEUMATELL received FDA 510(k) clearance on 1979-03-15, under 510(k) number K790351.

Who is the listed applicant for RHEUMATELL?

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

What is the FDA product code for RHEUMATELL?

The FDA product code for RHEUMATELL is DHR.

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 Central Biological Co. 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.

K812330DIALYSATE CONCENTRATEK792238CRPTELLK792027PREGTELL IK790801STERILE DEFIBRINATED SHEEP BLOOD

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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