FDA 510(k)

BIPOLAR, STANICOR LAMBDA MODEL 236,235

K-Number: K790014 · 1979-02-08

Decision Date1979-02-08

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BIPOLAR, STANICOR LAMBDA MODEL 236,235 is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1979-02-08 under 510(k) number K790014. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIPOLAR, STANICOR LAMBDA MODEL 236,235?

BIPOLAR, STANICOR LAMBDA MODEL 236,235 is a medical device that received FDA 510(k) clearance on 1979-02-08. The listed applicant is Cordis Corp.. The 510(k) number is K790014.

When did BIPOLAR, STANICOR LAMBDA MODEL 236,235 receive FDA 510(k) clearance?

BIPOLAR, STANICOR LAMBDA MODEL 236,235 received FDA 510(k) clearance on 1979-02-08, under 510(k) number K790014.

Who is the listed applicant for BIPOLAR, STANICOR LAMBDA MODEL 236,235?

The FDA 510(k) record lists Cordis Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIPOLAR, STANICOR LAMBDA MODEL 236,235?

The FDA product code for BIPOLAR, STANICOR LAMBDA MODEL 236,235 is DXY. This falls under the Clinical Chemistry category.

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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.