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FDA 510(k)

UNIVAL CONTROL CELLS

K-Number: K761284 · 1977-01-25

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1977-01-25
Product CodeKSF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

UNIVAL CONTROL CELLS 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 1977-01-25 under 510(k) number K761284. The device is classified under product code KSF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVAL CONTROL CELLS?

UNIVAL CONTROL CELLS is a medical device that received FDA 510(k) clearance on 1977-01-25. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K761284.

When did UNIVAL CONTROL CELLS receive FDA 510(k) clearance?

UNIVAL CONTROL CELLS received FDA 510(k) clearance on 1977-01-25, under 510(k) number K761284.

Who is the listed applicant for UNIVAL CONTROL CELLS?

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 UNIVAL CONTROL CELLS?

The FDA product code for UNIVAL CONTROL CELLS is KSF.

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Other records listing Dade, Baxter Travenol Diagnostics, Inc. as applicant

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Related Devices (Code: KSF)

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.

K811713AVI-D CONTROLOrtho Diagnostic Systems, Inc.K810599DADE RH CONTROL REAGENTAmerican DadeK801425RH CONTROLNorth American Biologicals, Inc.K800658RST-SERIES CONTROLGamma Biologicals, Inc.K800310ORTHO ANTISERA CONTROLOrtho Diagnostics, Inc.K800239RH-HR NEGATIVE CONTROL REAGENTGotham Biologics, Inc.

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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