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FDA 510(k)

TINA-QUANT FERRITIN ASSAY

K-Number: K964282 · 1997-07-30

ApplicantBoehringer Mannheim Corp.
Decision Date1997-07-30
Product CodeJMG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT FERRITIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1997-07-30 under 510(k) number K964282. 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 TINA-QUANT FERRITIN ASSAY?

TINA-QUANT FERRITIN ASSAY is a medical device that received FDA 510(k) clearance on 1997-07-30. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K964282.

When did TINA-QUANT FERRITIN ASSAY receive FDA 510(k) clearance?

TINA-QUANT FERRITIN ASSAY received FDA 510(k) clearance on 1997-07-30, under 510(k) number K964282.

Who is the listed applicant for TINA-QUANT FERRITIN ASSAY?

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

What is the FDA product code for TINA-QUANT FERRITIN ASSAY?

The FDA product code for TINA-QUANT FERRITIN ASSAY is JMG.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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Related Devices (Code: JMG)

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K234052Access FerritinBeckman Coulter, Inc.K052082FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020Beckman Coulter, Inc.K971833ELECSYS FERRITINBoehringer Mannheim Corp.K963498FERR FLEX REAGENT CARTRIDGEDade Chemistry Systems, Inc.K950393ACE(TM) CEDIA(R) FERRITIN ASSAYSchiapparelli Biosystems, Inc.K925848IMMULITE FERRITINDiagnostic Products 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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