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FDA 510(k)

ORTHO FACTOR XII DEFICIENT PLASMA

K-Number: K883688 · 1988-11-01

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1988-11-01
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORTHO FACTOR XII DEFICIENT PLASMA 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 1988-11-01 under 510(k) number K883688. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO FACTOR XII DEFICIENT PLASMA?

ORTHO FACTOR XII DEFICIENT PLASMA is a medical device that received FDA 510(k) clearance on 1988-11-01. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K883688.

When did ORTHO FACTOR XII DEFICIENT PLASMA receive FDA 510(k) clearance?

ORTHO FACTOR XII DEFICIENT PLASMA received FDA 510(k) clearance on 1988-11-01, under 510(k) number K883688.

Who is the listed applicant for ORTHO FACTOR XII DEFICIENT PLASMA?

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 FACTOR XII DEFICIENT PLASMA?

The FDA product code for ORTHO FACTOR XII DEFICIENT PLASMA is GJT.

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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: GJT)

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.

K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory COK102851NOFACT VIIIR2 Diagnostics, Inc.K102908NOFACT IXR2 Diagnostics, Inc.K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAInstrumentation Laboratory COK050661HEMOSIL FACTOR II DEFICIENT PLASMAInstrumentation Laboratory CO

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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