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FDA 510(k)

T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE

K-Number: K880388 · 1988-03-03

ApplicantSerono Diagnostics, Inc.
Decision Date1988-03-03
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-03-03 under 510(k) number K880388. 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 T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE?

T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE is a medical device that received FDA 510(k) clearance on 1988-03-03. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K880388.

When did T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE receive FDA 510(k) clearance?

T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE received FDA 510(k) clearance on 1988-03-03, under 510(k) number K880388.

Who is the listed applicant for T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE?

The FDA 510(k) record lists Serono Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE?

The FDA product code for T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE is CDP.

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Other records listing Serono Diagnostics, Inc. 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.

K953598SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERSK942051SR1 DHEA-S ENZYME IMMUNOASSAYK883085T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHASK882340LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHAK874866T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASEK873431PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH

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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.K983434ABBOTT ARCHITECT TOTAL 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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