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FDA 510(k)

T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS

K-Number: K883085 · 1988-09-09

ApplicantSerono Diagnostics, Inc.
Decision Date1988-09-09
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS 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 1988-09-09 under 510(k) number K883085. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS?

T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS is a medical device that received FDA 510(k) clearance on 1988-09-09. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K883085.

When did T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS receive FDA 510(k) clearance?

T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS received FDA 510(k) clearance on 1988-09-09, under 510(k) number K883085.

Who is the listed applicant for T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS?

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 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS?

The FDA product code for T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS is KHQ.

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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 IMMUNOASSAYK882340LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHAK880388T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASEK874866T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASEK873431PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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