Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY

K-Number: K933414 · 1994-11-22

ApplicantBaxter Diagnostics, Inc.
Decision Date1994-11-22
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K933414. 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 STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY?

STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K933414.

When did STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1994-11-22, under 510(k) number K933414.

Who is the listed applicant for STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY?

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

What is the FDA product code for STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY?

The FDA product code for STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY is KHQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Baxter 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

View all 72 devices →

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.

↑