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FDA 510(k)

PROC APC ASSAY, PROC CONTROL PLASMA

K-Number: K962968 · 1996-12-13

ApplicantBehring Diagnostics, Inc.
Decision Date1996-12-13
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROC APC ASSAY, PROC CONTROL PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-12-13 under 510(k) number K962968. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROC APC ASSAY, PROC CONTROL PLASMA?

PROC APC ASSAY, PROC CONTROL PLASMA is a medical device that received FDA 510(k) clearance on 1996-12-13. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K962968.

When did PROC APC ASSAY, PROC CONTROL PLASMA receive FDA 510(k) clearance?

PROC APC ASSAY, PROC CONTROL PLASMA received FDA 510(k) clearance on 1996-12-13, under 510(k) number K962968.

Who is the listed applicant for PROC APC ASSAY, PROC CONTROL PLASMA?

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

What is the FDA product code for PROC APC ASSAY, PROC CONTROL PLASMA?

The FDA product code for PROC APC ASSAY, PROC CONTROL PLASMA is GGP.

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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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