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FDA 510(k)

D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.

K-Number: K896329 · 1989-12-12

ApplicantPhotec Diagnostics, Inc.
Decision Date1989-12-12
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. is the device name listed in this FDA 510(k) record. The listed applicant is Photec Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-12-12 under 510(k) number K896329. 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 D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.?

D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. is a medical device that received FDA 510(k) clearance on 1989-12-12. The listed applicant is Photec Diagnostics, Inc.. The 510(k) number is K896329.

When did D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. receive FDA 510(k) clearance?

D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. received FDA 510(k) clearance on 1989-12-12, under 510(k) number K896329.

Who is the listed applicant for D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.?

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

What is the FDA product code for D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.?

The FDA product code for D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. is KLI.

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Other records listing Photec 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.

K897169QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KITK894057QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KITK892224D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMINK890267QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMAK890027QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOODK882307D-CHEM

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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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