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FDA 510(k)

LEECO TESTO-QUANT DIAG. KIT

K-Number: K813059 · 1981-11-16

ApplicantLeeco Diagnostics, Inc.
Decision Date1981-11-16
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEECO TESTO-QUANT DIAG. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K813059. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEECO TESTO-QUANT DIAG. KIT?

LEECO TESTO-QUANT DIAG. KIT is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K813059.

When did LEECO TESTO-QUANT DIAG. KIT receive FDA 510(k) clearance?

LEECO TESTO-QUANT DIAG. KIT received FDA 510(k) clearance on 1981-11-16, under 510(k) number K813059.

Who is the listed applicant for LEECO TESTO-QUANT DIAG. KIT?

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

What is the FDA product code for LEECO TESTO-QUANT DIAG. KIT?

The FDA product code for LEECO TESTO-QUANT DIAG. KIT is CDZ.

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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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