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FDA 510(k)

MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT

K-Number: K050960 · 2005-07-11

ApplicantWallac OY
Decision Date2005-07-11
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L 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 2005-07-11 under 510(k) number K050960. 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 MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT?

MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT is a medical device that received FDA 510(k) clearance on 2005-07-11. The listed applicant is Wallac OY. The 510(k) number is K050960.

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

MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT received FDA 510(k) clearance on 2005-07-11, under 510(k) number K050960.

Who is the listed applicant for MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L 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 MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT?

The FDA product code for MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L 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-GenesisK042425AUTODELFIA NEONATAL 17A-OH-PROGESTERONE 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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