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FDA 510(k)

IMMULITE THYROID AUTOANTIBODY CONTROL MODULE

K-Number: K971051 · 1997-04-10

ApplicantDiagnostic Products Corp.
Decision Date1997-04-10
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE THYROID AUTOANTIBODY CONTROL MODULE 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 1997-04-10 under 510(k) number K971051. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE THYROID AUTOANTIBODY CONTROL MODULE?

IMMULITE THYROID AUTOANTIBODY CONTROL MODULE is a medical device that received FDA 510(k) clearance on 1997-04-10. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K971051.

When did IMMULITE THYROID AUTOANTIBODY CONTROL MODULE receive FDA 510(k) clearance?

IMMULITE THYROID AUTOANTIBODY CONTROL MODULE received FDA 510(k) clearance on 1997-04-10, under 510(k) number K971051.

Who is the listed applicant for IMMULITE THYROID AUTOANTIBODY CONTROL MODULE?

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 THYROID AUTOANTIBODY CONTROL MODULE?

The FDA product code for IMMULITE THYROID AUTOANTIBODY CONTROL MODULE is JJX.

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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

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Related Devices (Code: JJX)

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.

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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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