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FDA 510(k)

AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT

K-Number: K042425 · 2004-09-30

ApplicantWallac OY
Decision Date2004-09-30
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Wallac OY. It received FDA 510(k) clearance on 2004-09-30 under 510(k) number K042425. 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 AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT?

AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT is a medical device that received FDA 510(k) clearance on 2004-09-30. The listed applicant is Wallac OY. The 510(k) number is K042425.

When did AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT receive FDA 510(k) clearance?

AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT received FDA 510(k) clearance on 2004-09-30, under 510(k) number K042425.

Who is the listed applicant for AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT?

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

What is the FDA product code for AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT?

The FDA product code for AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT is JLX.

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Other records listing Wallac OY 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.

K131284GSP NEONATAL BIOTINIDASE KITK100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UK081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITK071649NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BK070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112K050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367

View all 21 devices →

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.K060452ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAHNeo-GenesisK050960MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KITWallac OYK042424DELFIA NEONATAL 17A-OH-PROGESTERONE KITWallac OY

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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