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FDA 510(k)

SYNTHAFAX APTT REAGENT

K-Number: K955638 · 1996-04-23

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1996-04-23
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYNTHAFAX APTT REAGENT 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 1996-04-23 under 510(k) number K955638. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHAFAX APTT REAGENT?

SYNTHAFAX APTT REAGENT is a medical device that received FDA 510(k) clearance on 1996-04-23. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K955638.

When did SYNTHAFAX APTT REAGENT receive FDA 510(k) clearance?

SYNTHAFAX APTT REAGENT received FDA 510(k) clearance on 1996-04-23, under 510(k) number K955638.

Who is the listed applicant for SYNTHAFAX APTT REAGENT?

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 SYNTHAFAX APTT REAGENT?

The FDA product code for SYNTHAFAX APTT REAGENT is GFO.

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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: GFO)

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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