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FDA 510(k)

IMMULITE FREE T4

K-Number: K931704 · 1993-08-16

ApplicantDiagnostic Products Corp.
Decision Date1993-08-16
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE FREE T4 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1993-08-16 under 510(k) number K931704. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE FREE T4?

IMMULITE FREE T4 is a medical device that received FDA 510(k) clearance on 1993-08-16. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K931704.

When did IMMULITE FREE T4 receive FDA 510(k) clearance?

IMMULITE FREE T4 received FDA 510(k) clearance on 1993-08-16, under 510(k) number K931704.

Who is the listed applicant for IMMULITE FREE T4?

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

What is the FDA product code for IMMULITE FREE T4?

The FDA product code for IMMULITE FREE T4 is CEC.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

View all 321 devices →

Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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