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FDA 510(k)

ORTHO*T-3 UPTAKE KIT

K-Number: K781482 · 1978-09-27

ApplicantOrtho Diagnostics, Inc.
Decision Date1978-09-27
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ORTHO*T-3 UPTAKE KIT 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 1978-09-27 under 510(k) number K781482. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO*T-3 UPTAKE KIT?

ORTHO*T-3 UPTAKE KIT is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K781482.

When did ORTHO*T-3 UPTAKE KIT receive FDA 510(k) clearance?

ORTHO*T-3 UPTAKE KIT received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781482.

Who is the listed applicant for ORTHO*T-3 UPTAKE KIT?

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 ORTHO*T-3 UPTAKE KIT?

The FDA product code for ORTHO*T-3 UPTAKE KIT is KHQ.

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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 CELLSK800357BI-LEVEL ASSAYED CARD. DRUG CONT., I,IIK800310ORTHO ANTISERA CONTROLK791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONK791301ORTHO TSH RIA KIT

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim 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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