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FDA 510(k)

ORTHO SPECTRUM III & ORTHO-MUNE OK

K-Number: K820643 · 1982-07-14

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1982-07-14
Product CodeLIZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORTHO SPECTRUM III & ORTHO-MUNE OK 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 1982-07-14 under 510(k) number K820643. The device is classified under product code LIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO SPECTRUM III & ORTHO-MUNE OK?

ORTHO SPECTRUM III & ORTHO-MUNE OK is a medical device that received FDA 510(k) clearance on 1982-07-14. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K820643.

When did ORTHO SPECTRUM III & ORTHO-MUNE OK receive FDA 510(k) clearance?

ORTHO SPECTRUM III & ORTHO-MUNE OK received FDA 510(k) clearance on 1982-07-14, under 510(k) number K820643.

Who is the listed applicant for ORTHO SPECTRUM III & ORTHO-MUNE OK?

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 SPECTRUM III & ORTHO-MUNE OK?

The FDA product code for ORTHO SPECTRUM III & ORTHO-MUNE OK is LIZ.

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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: LIZ)

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.

K914847CD8 MONOCLONAL ANTIBODIESGen Trak, Inc.K860830TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHODTechnicon Instruments Corp.K843062TBM-REAGENT FOR T,B CELL & MONOCYTESBd Becton Dickinson Vacutainer Systems PreanalyticK842218ANTI-LEU-4 FITC LYSIN C BUFFERBd Becton Dickinson Vacutainer Systems PreanalyticK833929WHITE BLOOD CELLS HUMAN TAND BControl DiagnosticsK831053QUANTIGEN T & B CELL ASSAYBio-Rad

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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