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FDA 510(k)

OPTICOAT T3 EIA KIT

K-Number: K981824 · 1998-12-22

ApplicantBiotecx Laboratories, Inc.
Decision Date1998-12-22
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPTICOAT T3 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 1998-12-22 under 510(k) number K981824. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTICOAT T3 EIA KIT?

OPTICOAT T3 EIA KIT is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Biotecx Laboratories, Inc.. The 510(k) number is K981824.

When did OPTICOAT T3 EIA KIT receive FDA 510(k) clearance?

OPTICOAT T3 EIA KIT received FDA 510(k) clearance on 1998-12-22, under 510(k) number K981824.

Who is the listed applicant for OPTICOAT T3 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 T3 EIA KIT?

The FDA product code for OPTICOAT T3 EIA KIT is CDP.

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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 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: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K983434ABBOTT ARCHITECT TOTAL T3Abbott LaboratoriesK983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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