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FDA 510(k)

HM-CAP EIA TEST (MODIFICATION)

K-Number: K955085 · 1996-02-09

ApplicantSchiff & Co.
Decision Date1996-02-09
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HM-CAP EIA TEST (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Schiff & Co.. It received FDA 510(k) clearance on 1996-02-09 under 510(k) number K955085. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HM-CAP EIA TEST (MODIFICATION)?

HM-CAP EIA TEST (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-02-09. The listed applicant is Schiff & Co.. The 510(k) number is K955085.

When did HM-CAP EIA TEST (MODIFICATION) receive FDA 510(k) clearance?

HM-CAP EIA TEST (MODIFICATION) received FDA 510(k) clearance on 1996-02-09, under 510(k) number K955085.

Who is the listed applicant for HM-CAP EIA TEST (MODIFICATION)?

The FDA 510(k) record lists Schiff & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HM-CAP EIA TEST (MODIFICATION)?

The FDA product code for HM-CAP EIA TEST (MODIFICATION) is LYR.

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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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