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FDA 510(k)

OPTICOAT T4 EIA KIT

K-Number: K982298 · 1999-02-03

ApplicantBiotecx Laboratories, Inc.
Decision Date1999-02-03
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPTICOAT T4 EIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biotecx Laboratories, Inc.. It received FDA 510(k) clearance on 1999-02-03 under 510(k) number K982298. 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 OPTICOAT T4 EIA KIT?

OPTICOAT T4 EIA KIT is a medical device that received FDA 510(k) clearance on 1999-02-03. The listed applicant is Biotecx Laboratories, Inc.. The 510(k) number is K982298.

When did OPTICOAT T4 EIA KIT receive FDA 510(k) clearance?

OPTICOAT T4 EIA KIT received FDA 510(k) clearance on 1999-02-03, under 510(k) number K982298.

Who is the listed applicant for OPTICOAT T4 EIA KIT?

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

What is the FDA product code for OPTICOAT T4 EIA KIT?

The FDA product code for OPTICOAT T4 EIA KIT is KLI.

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Other records listing Biotecx Laboratories, 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.

K981824OPTICOAT T3 EIA KITK895407CORTISOL CLASP-BEAD EIA KITK893620T3 CLASP-BEAD EIA KITK892853T4 CLASP-BEAD EIA KITK883765TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINEK871211PROGESTERONE CLASP RADIOIMMUNOASSAY KIT

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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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