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FDA 510(k)

ORTHO ABNORMAL PROTEIN C CONTROL PLASMA

K-Number: K901233 · 1990-04-11

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1990-04-11
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORTHO ABNORMAL PROTEIN C CONTROL 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 1990-04-11 under 510(k) number K901233. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO ABNORMAL PROTEIN C CONTROL PLASMA?

ORTHO ABNORMAL PROTEIN C CONTROL PLASMA is a medical device that received FDA 510(k) clearance on 1990-04-11. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K901233.

When did ORTHO ABNORMAL PROTEIN C CONTROL PLASMA receive FDA 510(k) clearance?

ORTHO ABNORMAL PROTEIN C CONTROL PLASMA received FDA 510(k) clearance on 1990-04-11, under 510(k) number K901233.

Who is the listed applicant for ORTHO ABNORMAL PROTEIN C CONTROL 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 ABNORMAL PROTEIN C CONTROL PLASMA?

The FDA product code for ORTHO ABNORMAL PROTEIN C CONTROL PLASMA is GGC.

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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: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, Inc.

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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