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FDA 510(k)

ELECSYS FT3

K-Number: K963127 · 1996-12-16

ApplicantBoehringer Mannheim Corp.
Decision Date1996-12-16
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS FT3 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 1996-12-16 under 510(k) number K963127. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS FT3?

ELECSYS FT3 is a medical device that received FDA 510(k) clearance on 1996-12-16. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K963127.

When did ELECSYS FT3 receive FDA 510(k) clearance?

ELECSYS FT3 received FDA 510(k) clearance on 1996-12-16, under 510(k) number K963127.

Who is the listed applicant for ELECSYS FT3?

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 FT3?

The FDA product code for ELECSYS FT3 is CDP.

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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: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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