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FDA 510(k)

PATHO DX LATEX AGGLUTINATION STREP B KIT

K-Number: K845022 · 1985-05-02

ApplicantDiagnostic Products Corp.
Decision Date1985-05-02
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PATHO DX LATEX AGGLUTINATION STREP B KIT 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 1985-05-02 under 510(k) number K845022. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHO DX LATEX AGGLUTINATION STREP B KIT?

PATHO DX LATEX AGGLUTINATION STREP B KIT is a medical device that received FDA 510(k) clearance on 1985-05-02. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K845022.

When did PATHO DX LATEX AGGLUTINATION STREP B KIT receive FDA 510(k) clearance?

PATHO DX LATEX AGGLUTINATION STREP B KIT received FDA 510(k) clearance on 1985-05-02, under 510(k) number K845022.

Who is the listed applicant for PATHO DX LATEX AGGLUTINATION STREP B KIT?

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 PATHO DX LATEX AGGLUTINATION STREP B KIT?

The FDA product code for PATHO DX LATEX AGGLUTINATION STREP B KIT is GTZ.

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Other records listing Diagnostic Products Corp. as applicant

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Related Devices (Code: GTZ)

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.

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.K011709UNI-GOLD STREP A TEST KITTrinity Biotech, PlcK010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTBinax, Inc.K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBinax, Inc.K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIAbbott LaboratoriesK962060STREP A OIA MAXBiostar, 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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