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FDA 510(k)

ORTHO*T-3 RIA (PEG) KIT

K-Number: K781481 · 1978-09-27

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

Device Summary

ORTHO*T-3 RIA (PEG) 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 K781481. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO*T-3 RIA (PEG) KIT?

ORTHO*T-3 RIA (PEG) 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 K781481.

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

ORTHO*T-3 RIA (PEG) KIT received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781481.

Who is the listed applicant for ORTHO*T-3 RIA (PEG) 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 RIA (PEG) KIT?

The FDA product code for ORTHO*T-3 RIA (PEG) KIT is CDP.

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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: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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