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FDA 510(k)

TENONE(TM) OPIATES CATALOG: VKSO1,4

K-Number: K902055 · 1990-07-10

ApplicantDiagnostic Products Corp.
Decision Date1990-07-10
Product CodeDDE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TENONE(TM) OPIATES CATALOG: VKSO1,4 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 1990-07-10 under 510(k) number K902055. The device is classified under product code DDE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENONE(TM) OPIATES CATALOG: VKSO1,4?

TENONE(TM) OPIATES CATALOG: VKSO1,4 is a medical device that received FDA 510(k) clearance on 1990-07-10. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K902055.

When did TENONE(TM) OPIATES CATALOG: VKSO1,4 receive FDA 510(k) clearance?

TENONE(TM) OPIATES CATALOG: VKSO1,4 received FDA 510(k) clearance on 1990-07-10, under 510(k) number K902055.

Who is the listed applicant for TENONE(TM) OPIATES CATALOG: VKSO1,4?

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) OPIATES CATALOG: VKSO1,4?

The FDA product code for TENONE(TM) OPIATES CATALOG: VKSO1,4 is DDE.

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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: DDE)

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.

K823680COAT-A-COUNT MORPHINE KIT & COMPONENTSDiagnostic Products Corp.K820900EMIT URINE METHADONE ASSAY #3E319Syva Co.

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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