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FDA 510(k)

EYE SPOT IM TEST

K-Number: K932688 · 1993-09-08

ApplicantJ.S. Medical Assoc.
Decision Date1993-09-08
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EYE SPOT IM TEST is the device name listed in this FDA 510(k) record. The listed applicant is J.S. Medical Assoc.. It received FDA 510(k) clearance on 1993-09-08 under 510(k) number K932688. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE SPOT IM TEST?

EYE SPOT IM TEST is a medical device that received FDA 510(k) clearance on 1993-09-08. The listed applicant is J.S. Medical Assoc.. The 510(k) number is K932688.

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

EYE SPOT IM TEST received FDA 510(k) clearance on 1993-09-08, under 510(k) number K932688.

Who is the listed applicant for EYE SPOT IM TEST?

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

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

The FDA product code for EYE SPOT IM TEST is KTN.

Other records listing J.S. Medical Assoc. 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.

K932752VISI-SPOTK932180EYE SPOT CRP TESTK932551ACCUTEX IM LATEX TESTK926112ACCUTEX BETA-HCG TESTK924332ACCUTEX CRP LATEX TESTK924247ACCUTEX ASO LATEX TEST

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Related Devices (Code: KTN)

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.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.

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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