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FDA 510(k)

TENONE(TM) METHAMPHETAMINE

K-Number: K910043 · 1991-02-14

ApplicantDiagnostic Products Corp.
Decision Date1991-02-14
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TENONE(TM) METHAMPHETAMINE 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 1991-02-14 under 510(k) number K910043. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENONE(TM) METHAMPHETAMINE?

TENONE(TM) METHAMPHETAMINE is a medical device that received FDA 510(k) clearance on 1991-02-14. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K910043.

When did TENONE(TM) METHAMPHETAMINE receive FDA 510(k) clearance?

TENONE(TM) METHAMPHETAMINE received FDA 510(k) clearance on 1991-02-14, under 510(k) number K910043.

Who is the listed applicant for TENONE(TM) METHAMPHETAMINE?

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 TENONE(TM) METHAMPHETAMINE?

The FDA product code for TENONE(TM) METHAMPHETAMINE is LAF.

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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: LAF)

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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