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FDA 510(k)

IMMU-TEK AUTOMATIC CENTRIFUGE

K-Number: K790767 · 1979-05-23

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1979-05-23
Product CodeKSN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMU-TEK AUTOMATIC CENTRIFUGE is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-05-23 under 510(k) number K790767. The device is classified under product code KSN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMU-TEK AUTOMATIC CENTRIFUGE?

IMMU-TEK AUTOMATIC CENTRIFUGE is a medical device that received FDA 510(k) clearance on 1979-05-23. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K790767.

When did IMMU-TEK AUTOMATIC CENTRIFUGE receive FDA 510(k) clearance?

IMMU-TEK AUTOMATIC CENTRIFUGE received FDA 510(k) clearance on 1979-05-23, under 510(k) number K790767.

Who is the listed applicant for IMMU-TEK AUTOMATIC CENTRIFUGE?

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

What is the FDA product code for IMMU-TEK AUTOMATIC CENTRIFUGE?

The FDA product code for IMMU-TEK AUTOMATIC CENTRIFUGE is KSN.

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Other records listing Dade, Baxter Travenol 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.

K800296WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3K792606WHOLE BLOOD PLATELET CONTROL NORMAL,K792723BLOOD FLUID FILTERSK792607T3 UPTAKE (T3U) REAGENTSK792443TSH RADIOIMMUNOASSAYK792442FERRITIN RADIOIMMUNOASSAY

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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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