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FDA 510(k)

QM300 RHEUMATOID FACTOR ANTIGEN PACK

K-Number: K883536 · 1988-09-07

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1988-09-07
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QM300 RHEUMATOID FACTOR ANTIGEN PACK is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1988-09-07 under 510(k) number K883536. 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 QM300 RHEUMATOID FACTOR ANTIGEN PACK?

QM300 RHEUMATOID FACTOR ANTIGEN PACK is a medical device that received FDA 510(k) clearance on 1988-09-07. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K883536.

When did QM300 RHEUMATOID FACTOR ANTIGEN PACK receive FDA 510(k) clearance?

QM300 RHEUMATOID FACTOR ANTIGEN PACK received FDA 510(k) clearance on 1988-09-07, under 510(k) number K883536.

Who is the listed applicant for QM300 RHEUMATOID FACTOR ANTIGEN PACK?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QM300 RHEUMATOID FACTOR ANTIGEN PACK?

The FDA product code for QM300 RHEUMATOID FACTOR ANTIGEN PACK is DHR.

Related Clinical Trials

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Other records listing Kallestad Diag, A Div. of Erbamont, 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.

K910887QM300 CONTROL G PACKK910886QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKK910885QM300 CALIBRATOR G PACKK904725CHLAMYDIA SYSTEM SOFTWARE (CSS)K902253PATHFINDER(TM) CHLAMYDIA MICROPLATE KITK902462MODIFIED QM300 RHEUMATOID FACTOR TEST

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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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