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FDA 510(k)

ELECSYS FT4 ASSAY

K-Number: K961489 · 1996-06-11

ApplicantBoehringer Mannheim Corp.
Decision Date1996-06-11
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS FT4 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 1996-06-11 under 510(k) number K961489. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS FT4 ASSAY?

ELECSYS FT4 ASSAY is a medical device that received FDA 510(k) clearance on 1996-06-11. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K961489.

When did ELECSYS FT4 ASSAY receive FDA 510(k) clearance?

ELECSYS FT4 ASSAY received FDA 510(k) clearance on 1996-06-11, under 510(k) number K961489.

Who is the listed applicant for ELECSYS FT4 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 ELECSYS FT4 ASSAY?

The FDA product code for ELECSYS FT4 ASSAY is CEC.

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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: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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