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FDA 510(k)

ORTHOKROME* FACTOR VIII

K-Number: K900395 · 1990-03-15

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1990-03-15
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORTHOKROME* FACTOR VIII 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 1990-03-15 under 510(k) number K900395. 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 ORTHOKROME* FACTOR VIII?

ORTHOKROME* FACTOR VIII is a medical device that received FDA 510(k) clearance on 1990-03-15. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K900395.

When did ORTHOKROME* FACTOR VIII receive FDA 510(k) clearance?

ORTHOKROME* FACTOR VIII received FDA 510(k) clearance on 1990-03-15, under 510(k) number K900395.

Who is the listed applicant for ORTHOKROME* FACTOR VIII?

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 ORTHOKROME* FACTOR VIII?

The FDA product code for ORTHOKROME* FACTOR VIII is GGP.

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Other records listing Ortho Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

View all 126 devices →

Related Devices (Code: GGP)

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.

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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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