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FDA 510(k)

TEST, LATEX SLIDE, RHEUMATOID FACTOR

K-Number: K760036 · 1976-08-03

ApplicantGamma Biologicals, Inc.
Decision Date1976-08-03
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TEST, LATEX SLIDE, RHEUMATOID FACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Biologicals, Inc.. It received FDA 510(k) clearance on 1976-08-03 under 510(k) number K760036. 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 TEST, LATEX SLIDE, RHEUMATOID FACTOR?

TEST, LATEX SLIDE, RHEUMATOID FACTOR is a medical device that received FDA 510(k) clearance on 1976-08-03. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K760036.

When did TEST, LATEX SLIDE, RHEUMATOID FACTOR receive FDA 510(k) clearance?

TEST, LATEX SLIDE, RHEUMATOID FACTOR received FDA 510(k) clearance on 1976-08-03, under 510(k) number K760036.

Who is the listed applicant for TEST, LATEX SLIDE, RHEUMATOID FACTOR?

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

What is the FDA product code for TEST, LATEX SLIDE, RHEUMATOID FACTOR?

The FDA product code for TEST, LATEX SLIDE, RHEUMATOID FACTOR is DHR.

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Other records listing Gamma Biologicals, 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.

K864207DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONOK861016GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSISK832473GAMMA SLIDE TEST FOR PREGNANCYK820647GAMMA FETAL BLEED SCREENING TESTK813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONK820072FE-CULT PLUS

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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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