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FDA 510(k)

PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1

K-Number: K983336 · 1999-03-18

ApplicantDiagnostic Products Corp.
Decision Date1999-03-18
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 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 1999-03-18 under 510(k) number K983336. The device is classified under product code LKT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1?

PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 is a medical device that received FDA 510(k) clearance on 1999-03-18. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K983336.

When did PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 receive FDA 510(k) clearance?

PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 received FDA 510(k) clearance on 1999-03-18, under 510(k) number K983336.

Who is the listed applicant for PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1?

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 PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1?

The FDA product code for PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 is LKT.

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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: LKT)

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.

K081928D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.K943317PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)Diagnostic Products Corp.K942173RSV ANTIGEN TESTNeogenexK912842RSV-MAB TESTGull Laboratories, Inc.K912838BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNOBaxter Diagnostics, Inc.K912371BIOMERIEUX RSV DIRECT IF KITVitek Systems, 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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