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FDA 510(k)

EYE SPOT RF TEST

K-Number: K932437 · 1993-08-23

ApplicantJ & S Medical Assoc., Inc.
Decision Date1993-08-23
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EYE SPOT RF TEST is the device name listed in this FDA 510(k) record. The listed applicant is J & S Medical Assoc., Inc.. It received FDA 510(k) clearance on 1993-08-23 under 510(k) number K932437. 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 EYE SPOT RF TEST?

EYE SPOT RF TEST is a medical device that received FDA 510(k) clearance on 1993-08-23. The listed applicant is J & S Medical Assoc., Inc.. The 510(k) number is K932437.

When did EYE SPOT RF TEST receive FDA 510(k) clearance?

EYE SPOT RF TEST received FDA 510(k) clearance on 1993-08-23, under 510(k) number K932437.

Who is the listed applicant for EYE SPOT RF TEST?

The FDA 510(k) record lists J & S Medical Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYE SPOT RF TEST?

The FDA product code for EYE SPOT RF TEST is DHR.

Other records listing J & S Medical Assoc., 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.

K022085J&S MEDICAL SENTRY URINE DIPSTICK CONTROL

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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