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FDA 510(k)

RF STAT IGM TEST KIT

K-Number: K920753 · 1992-03-30

ApplicantBiowhittaker Molecular Applications, Inc.
Decision Date1992-03-30
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RF STAT IGM TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biowhittaker Molecular Applications, Inc.. It received FDA 510(k) clearance on 1992-03-30 under 510(k) number K920753. 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 RF STAT IGM TEST KIT?

RF STAT IGM TEST KIT is a medical device that received FDA 510(k) clearance on 1992-03-30. The listed applicant is Biowhittaker Molecular Applications, Inc.. The 510(k) number is K920753.

When did RF STAT IGM TEST KIT receive FDA 510(k) clearance?

RF STAT IGM TEST KIT received FDA 510(k) clearance on 1992-03-30, under 510(k) number K920753.

Who is the listed applicant for RF STAT IGM TEST KIT?

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

What is the FDA product code for RF STAT IGM TEST KIT?

The FDA product code for RF STAT IGM TEST KIT is DHR.

Other records listing Biowhittaker Molecular Applications, 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.

K943843VARICELISA, MODIFICATIONK942361WHITSOFTK942250BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READERK942245BIOWHITTAKER 2001 MICROPLATE READER FIRMWAREK925209MUMPS STATK935618SPECIMEN TRANSPORT MEDIUM

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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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