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FDA 510(k)

IRMA TEST, NORDICLAB FERRITIN

K-Number: K782157 · 1979-01-17

ApplicantNordiclab Intl.
Decision Date1979-01-17
Product CodeJMG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IRMA TEST, NORDICLAB FERRITIN is the device name listed in this FDA 510(k) record. The listed applicant is Nordiclab Intl.. It received FDA 510(k) clearance on 1979-01-17 under 510(k) number K782157. The device is classified under product code JMG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRMA TEST, NORDICLAB FERRITIN?

IRMA TEST, NORDICLAB FERRITIN is a medical device that received FDA 510(k) clearance on 1979-01-17. The listed applicant is Nordiclab Intl.. The 510(k) number is K782157.

When did IRMA TEST, NORDICLAB FERRITIN receive FDA 510(k) clearance?

IRMA TEST, NORDICLAB FERRITIN received FDA 510(k) clearance on 1979-01-17, under 510(k) number K782157.

Who is the listed applicant for IRMA TEST, NORDICLAB FERRITIN?

The FDA 510(k) record lists Nordiclab Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRMA TEST, NORDICLAB FERRITIN?

The FDA product code for IRMA TEST, NORDICLAB FERRITIN is JMG.

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Other records listing Nordiclab Intl. 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.

K801988NORDICLAB PROSTATIC ACID PHOSPHATASE RIAK801989NORDICLAB FERRITIN IRMA TESTK800920NORDICLAB ESTRADIOL RIA TESTK800922NORDICLAB PROGESTERONE RIA TESTK800921NORDICLAB TESTOSTERONE RIA TESTK792189NORDICLAB TOTAL ESTRIOL RIA TEST

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Related Devices (Code: JMG)

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.

K234052Access FerritinBeckman Coulter, Inc.K052082FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020Beckman Coulter, Inc.K964282TINA-QUANT FERRITIN ASSAYBoehringer Mannheim Corp.K971833ELECSYS FERRITINBoehringer Mannheim Corp.K963498FERR FLEX REAGENT CARTRIDGEDade Chemistry Systems, Inc.K950393ACE(TM) CEDIA(R) FERRITIN ASSAYSchiapparelli Biosystems, Inc.

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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