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FDA 510(k)

RDW AND MPV INDICES ON HEMAT 12

K-Number: K900684 · 1990-04-16

ApplicantTexas Intl. Laboratories, Inc.
Decision Date1990-04-16
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RDW AND MPV INDICES ON HEMAT 12 is the device name listed in this FDA 510(k) record. The listed applicant is Texas Intl. Laboratories, Inc.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K900684. 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 RDW AND MPV INDICES ON HEMAT 12?

RDW AND MPV INDICES ON HEMAT 12 is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Texas Intl. Laboratories, Inc.. The 510(k) number is K900684.

When did RDW AND MPV INDICES ON HEMAT 12 receive FDA 510(k) clearance?

RDW AND MPV INDICES ON HEMAT 12 received FDA 510(k) clearance on 1990-04-16, under 510(k) number K900684.

Who is the listed applicant for RDW AND MPV INDICES ON HEMAT 12?

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

What is the FDA product code for RDW AND MPV INDICES ON HEMAT 12?

The FDA product code for RDW AND MPV INDICES ON HEMAT 12 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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