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FDA 510(k)

IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5

K-Number: K992632 · 2000-01-27

ApplicantDiagnostic Products Corp.
Decision Date2000-01-27
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 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 2000-01-27 under 510(k) number K992632. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5?

IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 is a medical device that received FDA 510(k) clearance on 2000-01-27. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K992632.

When did IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 receive FDA 510(k) clearance?

IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 received FDA 510(k) clearance on 2000-01-27, under 510(k) number K992632.

Who is the listed applicant for IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5?

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 AMPHETAMINE, MODELS LKAM1, LKAM5?

The FDA product code for IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 is DKZ.

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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: DKZ)

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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