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FDA 510(k)

ELECSYS T4 ASSAY

K-Number: K961490 · 1996-06-13

ApplicantBoehringer Mannheim Corp.
Decision Date1996-06-13
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS T4 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 1996-06-13 under 510(k) number K961490. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS T4 ASSAY?

ELECSYS T4 ASSAY is a medical device that received FDA 510(k) clearance on 1996-06-13. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K961490.

When did ELECSYS T4 ASSAY receive FDA 510(k) clearance?

ELECSYS T4 ASSAY received FDA 510(k) clearance on 1996-06-13, under 510(k) number K961490.

Who is the listed applicant for ELECSYS T4 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 T4 ASSAY?

The FDA product code for ELECSYS T4 ASSAY is CDX.

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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: CDX)

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.

K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, Inc.K931295IQ TT4 ASSAYBecton Dickinson Advanced Diagnostics

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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