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FDA 510(k)

T4 CLASP-BEAD EIA KIT

K-Number: K892853 · 1989-05-22

ApplicantBiotecx Laboratories, Inc.
Decision Date1989-05-22
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T4 CLASP-BEAD 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 1989-05-22 under 510(k) number K892853. 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 CLASP-BEAD EIA KIT?

T4 CLASP-BEAD EIA KIT is a medical device that received FDA 510(k) clearance on 1989-05-22. The listed applicant is Biotecx Laboratories, Inc.. The 510(k) number is K892853.

When did T4 CLASP-BEAD EIA KIT receive FDA 510(k) clearance?

T4 CLASP-BEAD EIA KIT received FDA 510(k) clearance on 1989-05-22, under 510(k) number K892853.

Who is the listed applicant for T4 CLASP-BEAD 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 T4 CLASP-BEAD EIA KIT?

The FDA product code for T4 CLASP-BEAD 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.

K982298OPTICOAT T4 EIA KITK981824OPTICOAT T3 EIA KITK895407CORTISOL CLASP-BEAD EIA KITK893620T3 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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