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FDA 510(k)

HEMA-TROL Q-CHECK

K-Number: K952385 · 1995-09-25

ApplicantMedical Specialties Intl., Inc.
Decision Date1995-09-25
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEMA-TROL Q-CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties Intl., Inc.. It received FDA 510(k) clearance on 1995-09-25 under 510(k) number K952385. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMA-TROL Q-CHECK?

HEMA-TROL Q-CHECK is a medical device that received FDA 510(k) clearance on 1995-09-25. The listed applicant is Medical Specialties Intl., Inc.. The 510(k) number is K952385.

When did HEMA-TROL Q-CHECK receive FDA 510(k) clearance?

HEMA-TROL Q-CHECK received FDA 510(k) clearance on 1995-09-25, under 510(k) number K952385.

Who is the listed applicant for HEMA-TROL Q-CHECK?

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

What is the FDA product code for HEMA-TROL Q-CHECK?

The FDA product code for HEMA-TROL Q-CHECK is JJY.

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Other records listing Medical Specialties Intl., Inc. as applicant

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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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