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FDA 510(k)

HERPESELECT 1 ELISA IGG, MODEL EL0910G

K-Number: K021429 · 2002-07-29

ApplicantFocus Technologies, Inc.
Decision Date2002-07-29
Product CodeMXJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPESELECT 1 ELISA IGG, MODEL EL0910G is the device name listed in this FDA 510(k) record. The listed applicant is Focus Technologies, Inc.. It received FDA 510(k) clearance on 2002-07-29 under 510(k) number K021429. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPESELECT 1 ELISA IGG, MODEL EL0910G?

HERPESELECT 1 ELISA IGG, MODEL EL0910G is a medical device that received FDA 510(k) clearance on 2002-07-29. The listed applicant is Focus Technologies, Inc.. The 510(k) number is K021429.

When did HERPESELECT 1 ELISA IGG, MODEL EL0910G receive FDA 510(k) clearance?

HERPESELECT 1 ELISA IGG, MODEL EL0910G received FDA 510(k) clearance on 2002-07-29, under 510(k) number K021429.

Who is the listed applicant for HERPESELECT 1 ELISA IGG, MODEL EL0910G?

The FDA 510(k) record lists Focus Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERPESELECT 1 ELISA IGG, MODEL EL0910G?

The FDA product code for HERPESELECT 1 ELISA IGG, MODEL EL0910G is MXJ.

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Other records listing Focus Technologies, Inc. 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.

K040854WEST NILE VIRUS IGM CAPTURE ELISAK031953WEST NILE VIRUS ELISA IGG, MODEL EL0300GK031952WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300MK021486HERPESELECT 2 ELISA IGG, MODEL ELO920G

Related Devices (Code: MXJ)

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.

K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A.K220923Elecsys HSV-1 IgG (08948844160)Roche DiagnosticsK181333ADVIA Centaur Herpes-1 IgGBiokit, S.A.K162276SeraQuest Herpes Type 1 Specific IgGQuest International, Inc.K120625ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSVRoche DiagnosticsK120959BIOPLEX 2200 HSV-1 AND HSV-2 IGG KITBio-Rad Laboratories

Official Source

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