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FDA 510(k)

ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

K-Number: K973966 · 1997-10-31

ApplicantBeckman Instruments, Inc.
Decision Date1997-10-31
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1997-10-31 under 510(k) number K973966. 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 ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER?

ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER is a medical device that received FDA 510(k) clearance on 1997-10-31. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K973966.

When did ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER receive FDA 510(k) clearance?

ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER received FDA 510(k) clearance on 1997-10-31, under 510(k) number K973966.

Who is the listed applicant for ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER?

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

What is the FDA product code for ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER?

The FDA product code for ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER is CDP.

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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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.K983434ABBOTT ARCHITECT TOTAL 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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