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FDA 510(k)

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE

K-Number: K062534 · 2008-01-29

ApplicantDrg Intl., Inc.
Decision Date2008-01-29
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE is the device name listed in this FDA 510(k) record. The listed applicant is Drg Intl., Inc.. It received FDA 510(k) clearance on 2008-01-29 under 510(k) number K062534. 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 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE?

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE is a medical device that received FDA 510(k) clearance on 2008-01-29. The listed applicant is Drg Intl., Inc.. The 510(k) number is K062534.

When did ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE receive FDA 510(k) clearance?

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE received FDA 510(k) clearance on 2008-01-29, under 510(k) number K062534.

Who is the listed applicant for ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE?

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

What is the FDA product code for ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE?

The FDA product code for ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE is JLX.

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Other records listing Drg Intl., 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.

K052649DRG SLV TESTOSTERONE ELISA TESTK051733ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOLK000043DRG AURICA ELISA TESTOSTERONE KIT

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 OYK060452ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAHNeo-GenesisK050960MODIFICATION 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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