FDA 510(k)

PLASMA, STANDARDIZED NORMAL

K-Number: K790204 · 1979-03-12

ApplicantDade, Baxter Travenol Diagnostics, Inc.

Decision Date1979-03-12

Product CodeJPA

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

PLASMA, STANDARDIZED NORMAL 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 1979-03-12 under 510(k) number K790204. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASMA, STANDARDIZED NORMAL?

PLASMA, STANDARDIZED NORMAL is a medical device that received FDA 510(k) clearance on 1979-03-12. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K790204.

When did PLASMA, STANDARDIZED NORMAL receive FDA 510(k) clearance?

PLASMA, STANDARDIZED NORMAL received FDA 510(k) clearance on 1979-03-12, under 510(k) number K790204.

Who is the listed applicant for PLASMA, STANDARDIZED NORMAL?

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 PLASMA, STANDARDIZED NORMAL?

The FDA product code for PLASMA, STANDARDIZED NORMAL is JPA.

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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.