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FDA 510(k)

IMMULITE OPIATES SCREEN/CONTROL MODULE

K-Number: K962323 · 1997-03-10

ApplicantDiagnostic Products Corp.
Decision Date1997-03-10
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMULITE OPIATES SCREEN/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 1997-03-10 under 510(k) number K962323. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE OPIATES SCREEN/CONTROL MODULE?

IMMULITE OPIATES SCREEN/CONTROL MODULE is a medical device that received FDA 510(k) clearance on 1997-03-10. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K962323.

When did IMMULITE OPIATES SCREEN/CONTROL MODULE receive FDA 510(k) clearance?

IMMULITE OPIATES SCREEN/CONTROL MODULE received FDA 510(k) clearance on 1997-03-10, under 510(k) number K962323.

Who is the listed applicant for IMMULITE OPIATES SCREEN/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 OPIATES SCREEN/CONTROL MODULE?

The FDA product code for IMMULITE OPIATES SCREEN/CONTROL MODULE is DJG.

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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: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, 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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