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FDA 510(k)

ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH

K-Number: K060452 · 2007-03-13

ApplicantNeo-Genesis
Decision Date2007-03-13
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH is the device name listed in this FDA 510(k) record. The listed applicant is Neo-Genesis. It received FDA 510(k) clearance on 2007-03-13 under 510(k) number K060452. The device is classified under product code JLX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH?

ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH is a medical device that received FDA 510(k) clearance on 2007-03-13. The listed applicant is Neo-Genesis. The 510(k) number is K060452.

When did ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH receive FDA 510(k) clearance?

ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH received FDA 510(k) clearance on 2007-03-13, under 510(k) number K060452.

Who is the listed applicant for ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH?

The FDA 510(k) record lists Neo-Genesis as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH?

The FDA product code for ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH is JLX.

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Related Devices (Code: JLX)

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.

K100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UWallac OYK081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITWallac OYK062534ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEDrg Intl., Inc.K050960MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KITWallac OYK042425AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITWallac OYK042424DELFIA NEONATAL 17A-OH-PROGESTERONE KITWallac OY

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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