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FDA 510(k)

COAT-A-COUNT(TM) FENTANYL (TKFN1)

K-Number: K891605 · 1989-09-28

ApplicantDiagnostic Products Corp.
Decision Date1989-09-28
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT(TM) FENTANYL (TKFN1) 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 1989-09-28 under 510(k) number K891605. 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 COAT-A-COUNT(TM) FENTANYL (TKFN1)?

COAT-A-COUNT(TM) FENTANYL (TKFN1) is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K891605.

When did COAT-A-COUNT(TM) FENTANYL (TKFN1) receive FDA 510(k) clearance?

COAT-A-COUNT(TM) FENTANYL (TKFN1) received FDA 510(k) clearance on 1989-09-28, under 510(k) number K891605.

Who is the listed applicant for COAT-A-COUNT(TM) FENTANYL (TKFN1)?

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 COAT-A-COUNT(TM) FENTANYL (TKFN1)?

The FDA product code for COAT-A-COUNT(TM) FENTANYL (TKFN1) 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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