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FDA 510(k)

21 HEMATOLOGY REAGENTS

K-Number: K853304 · 1985-11-12

ApplicantIn Vitro Diagnostics, Inc.
Decision Date1985-11-12
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

21 HEMATOLOGY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is In Vitro Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K853304. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 21 HEMATOLOGY REAGENTS?

21 HEMATOLOGY REAGENTS is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is In Vitro Diagnostics, Inc.. The 510(k) number is K853304.

When did 21 HEMATOLOGY REAGENTS receive FDA 510(k) clearance?

21 HEMATOLOGY REAGENTS received FDA 510(k) clearance on 1985-11-12, under 510(k) number K853304.

Who is the listed applicant for 21 HEMATOLOGY REAGENTS?

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

What is the FDA product code for 21 HEMATOLOGY REAGENTS?

The FDA product code for 21 HEMATOLOGY REAGENTS is GKZ.

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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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