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FDA 510(k)

STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.

K-Number: K894993 · 1989-10-13

ApplicantBaxter Healthcare Corp
Decision Date1989-10-13
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-10-13 under 510(k) number K894993. 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 STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.?

STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. is a medical device that received FDA 510(k) clearance on 1989-10-13. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K894993.

When did STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. receive FDA 510(k) clearance?

STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. received FDA 510(k) clearance on 1989-10-13, under 510(k) number K894993.

Who is the listed applicant for STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.?

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

What is the FDA product code for STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.?

The FDA product code for STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. is CDP.

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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.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT 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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