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FDA 510(k)

PARAGON ACID HEMOGLOBIN REAGENT KIT

K-Number: K834595 · 1984-05-07

ApplicantBeckman Instruments, Inc.
Decision Date1984-05-07
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PARAGON ACID HEMOGLOBIN REAGENT KIT 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 1984-05-07 under 510(k) number K834595. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAGON ACID HEMOGLOBIN REAGENT KIT?

PARAGON ACID HEMOGLOBIN REAGENT KIT is a medical device that received FDA 510(k) clearance on 1984-05-07. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K834595.

When did PARAGON ACID HEMOGLOBIN REAGENT KIT receive FDA 510(k) clearance?

PARAGON ACID HEMOGLOBIN REAGENT KIT received FDA 510(k) clearance on 1984-05-07, under 510(k) number K834595.

Who is the listed applicant for PARAGON ACID HEMOGLOBIN REAGENT KIT?

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 PARAGON ACID HEMOGLOBIN REAGENT KIT?

The FDA product code for PARAGON ACID HEMOGLOBIN REAGENT KIT is GKA.

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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: GKA)

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.

K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebiaK222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech)K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlHelena Laboratories, Corp.K180762CAPI 3 HEMOGLOBIN(E)SebiaK171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc.K112550CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEMSebia

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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