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FDA 510(k)

LEECO DIG-QUANT DIAG. TEST KIT

K-Number: K830785 · 1983-04-08

ApplicantLeeco Diagnostics, Inc.
Decision Date1983-04-08
Product Code
DecisionSubstantially Equivalent

Device Summary

LEECO DIG-QUANT DIAG. TEST 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 1983-04-08 under 510(k) number K830785. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEECO DIG-QUANT DIAG. TEST KIT?

LEECO DIG-QUANT DIAG. TEST KIT is a medical device that received FDA 510(k) clearance on 1983-04-08. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K830785.

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

LEECO DIG-QUANT DIAG. TEST KIT received FDA 510(k) clearance on 1983-04-08, under 510(k) number K830785.

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

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

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Other records listing Leeco Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K895765LEECO PREVIEW(R) EBV (EIA)K894122LEECO VIS-DISK STREP-A (EIA)K891096VIS-DISK HCG (EIA) JPL-041MK891095VIS-DISK HCG (EIA) LYOPHILIZED JPL-044MK883269PRL-QUANTK880577CONCEP-7-BHCG

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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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