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FDA 510(k)

FETALSCREEN

K-Number: K820199 · 1982-05-12

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1982-05-12
Product Code
DecisionSubstantially Equivalent

Device Summary

FETALSCREEN 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 1982-05-12 under 510(k) number K820199. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETALSCREEN?

FETALSCREEN is a medical device that received FDA 510(k) clearance on 1982-05-12. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K820199.

When did FETALSCREEN receive FDA 510(k) clearance?

FETALSCREEN received FDA 510(k) clearance on 1982-05-12, under 510(k) number K820199.

Who is the listed applicant for FETALSCREEN?

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

Related Clinical Trials

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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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)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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