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FDA 510(k)

HM-CAP EIA KIT

K-Number: K944159 · 1995-07-18

ApplicantSchiff & Co.
Decision Date1995-07-18
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HM-CAP EIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Schiff & Co.. It received FDA 510(k) clearance on 1995-07-18 under 510(k) number K944159. 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 KIT?

HM-CAP EIA KIT is a medical device that received FDA 510(k) clearance on 1995-07-18. The listed applicant is Schiff & Co.. The 510(k) number is K944159.

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

HM-CAP EIA KIT received FDA 510(k) clearance on 1995-07-18, under 510(k) number K944159.

Who is the listed applicant for HM-CAP EIA KIT?

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 KIT?

The FDA product code for HM-CAP EIA KIT is LYR.

Other records listing Schiff & Co. 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.

View all 15 devices →

Related Devices (Code: LYR)

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.

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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