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FDA 510(k)

ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN

K-Number: K820392 · 1982-03-04

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1982-03-04
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN 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 1982-03-04 under 510(k) number K820392. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN?

ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN is a medical device that received FDA 510(k) clearance on 1982-03-04. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K820392.

When did ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN receive FDA 510(k) clearance?

ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN received FDA 510(k) clearance on 1982-03-04, under 510(k) number K820392.

Who is the listed applicant for ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN?

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* BI-LEVEL ASSAYED ALCOHOL DILUEN?

The FDA product code for ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN is LAS.

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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: LAS)

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.

K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbHK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics Corp.

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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