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FDA 510(k)

HICHEM ISEKCI SOLUTION KIT 70010

K-Number: K953862 · 1995-09-06

ApplicantHichem Diagnostics
Decision Date1995-09-06
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM ISEKCI SOLUTION KIT 70010 is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1995-09-06 under 510(k) number K953862. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HICHEM ISEKCI SOLUTION KIT 70010?

HICHEM ISEKCI SOLUTION KIT 70010 is a medical device that received FDA 510(k) clearance on 1995-09-06. The listed applicant is Hichem Diagnostics. The 510(k) number is K953862.

When did HICHEM ISEKCI SOLUTION KIT 70010 receive FDA 510(k) clearance?

HICHEM ISEKCI SOLUTION KIT 70010 received FDA 510(k) clearance on 1995-09-06, under 510(k) number K953862.

Who is the listed applicant for HICHEM ISEKCI SOLUTION KIT 70010?

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

What is the FDA product code for HICHEM ISEKCI SOLUTION KIT 70010?

The FDA product code for HICHEM ISEKCI SOLUTION KIT 70010 is CGZ.

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Other records listing Hichem Diagnostics as applicant

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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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