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FDA 510(k)

BI-LEVEL ASSAYED CARD. DRUG CONT., I,II

K-Number: K800357 · 1980-04-16

ApplicantOrtho Diagnostics, Inc.
Decision Date1980-04-16
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BI-LEVEL ASSAYED CARD. DRUG CONT., I,II is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostics, Inc.. It received FDA 510(k) clearance on 1980-04-16 under 510(k) number K800357. 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 BI-LEVEL ASSAYED CARD. DRUG CONT., I,II?

BI-LEVEL ASSAYED CARD. DRUG CONT., I,II is a medical device that received FDA 510(k) clearance on 1980-04-16. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K800357.

When did BI-LEVEL ASSAYED CARD. DRUG CONT., I,II receive FDA 510(k) clearance?

BI-LEVEL ASSAYED CARD. DRUG CONT., I,II received FDA 510(k) clearance on 1980-04-16, under 510(k) number K800357.

Who is the listed applicant for BI-LEVEL ASSAYED CARD. DRUG CONT., I,II?

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

What is the FDA product code for BI-LEVEL ASSAYED CARD. DRUG CONT., I,II?

The FDA product code for BI-LEVEL ASSAYED CARD. DRUG CONT., I,II is LAS.

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Other records listing Ortho Diagnostics, 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.

K802404ORTHO BOVINE ALBUMIN SOLUTION 30% PROTEK801507ANTIGEN CONTROL CELLSK800310ORTHO ANTISERA CONTROLK791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONK791301ORTHO TSH RIA KITK790813MULTECON BLOOD GAS CONTROL

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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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