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FDA 510(k)

T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE

K-Number: K874866 · 1988-02-11

ApplicantSerono Diagnostics, Inc.
Decision Date1988-02-11
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T4 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 1988-02-11 under 510(k) number K874866. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE?

T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE is a medical device that received FDA 510(k) clearance on 1988-02-11. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K874866.

When did T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE receive FDA 510(k) clearance?

T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE received FDA 510(k) clearance on 1988-02-11, under 510(k) number K874866.

Who is the listed applicant for T4 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 T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE?

The FDA product code for T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE is KLI.

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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 PHAK880388T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASEK873431PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH

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Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, 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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