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FDA 510(k)

ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL

K-Number: K940209 · 1995-05-11

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1995-05-11
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K940209. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL?

ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K940209.

When did ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL receive FDA 510(k) clearance?

ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL received FDA 510(k) clearance on 1995-05-11, under 510(k) number K940209.

Who is the listed applicant for ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL?

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

What is the FDA product code for ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL?

The FDA product code for ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL is GGN.

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Other records listing Ortho Diagnostic Systems, Inc. as applicant

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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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