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FDA 510(k)

ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L

K-Number: K852834 · 1985-08-08

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1985-08-08
Product Code
DecisionSubstantially Equivalent

Device Summary

ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L 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 1985-08-08 under 510(k) number K852834. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L?

ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L is a medical device that received FDA 510(k) clearance on 1985-08-08. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K852834.

When did ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L receive FDA 510(k) clearance?

ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L received FDA 510(k) clearance on 1985-08-08, under 510(k) number K852834.

Who is the listed applicant for ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L?

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

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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 →

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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