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FDA 510(k)

REAADS-RF TEST KIT-QUANTITATIVE

K-Number: K892444 · 1989-06-05

ApplicantBiosearch Medical Products, Inc.
Decision Date1989-06-05
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

REAADS-RF TEST KIT-QUANTITATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Biosearch Medical Products, Inc.. It received FDA 510(k) clearance on 1989-06-05 under 510(k) number K892444. 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 REAADS-RF TEST KIT-QUANTITATIVE?

REAADS-RF TEST KIT-QUANTITATIVE is a medical device that received FDA 510(k) clearance on 1989-06-05. The listed applicant is Biosearch Medical Products, Inc.. The 510(k) number is K892444.

When did REAADS-RF TEST KIT-QUANTITATIVE receive FDA 510(k) clearance?

REAADS-RF TEST KIT-QUANTITATIVE received FDA 510(k) clearance on 1989-06-05, under 510(k) number K892444.

Who is the listed applicant for REAADS-RF TEST KIT-QUANTITATIVE?

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

What is the FDA product code for REAADS-RF TEST KIT-QUANTITATIVE?

The FDA product code for REAADS-RF TEST KIT-QUANTITATIVE is DHR.

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Other records listing Biosearch Medical Products, Inc. as applicant

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K051480ENTERAL FEEDING TUBEK970145PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)K964871BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTSK951260URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANTK944614MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEMK932295NON-BALLOON REPLACEMENT GASTROSTOMY KIT

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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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