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FDA 510(k)

HICHEM ISE INTDERNAL REFERENCE KIT 70009

K-Number: K953861 · 1995-09-06

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

Device Summary

HICHEM ISE INTDERNAL REFERENCE KIT 70009 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 K953861. 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 ISE INTDERNAL REFERENCE KIT 70009?

HICHEM ISE INTDERNAL REFERENCE KIT 70009 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 K953861.

When did HICHEM ISE INTDERNAL REFERENCE KIT 70009 receive FDA 510(k) clearance?

HICHEM ISE INTDERNAL REFERENCE KIT 70009 received FDA 510(k) clearance on 1995-09-06, under 510(k) number K953861.

Who is the listed applicant for HICHEM ISE INTDERNAL REFERENCE KIT 70009?

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 ISE INTDERNAL REFERENCE KIT 70009?

The FDA product code for HICHEM ISE INTDERNAL REFERENCE KIT 70009 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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