Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U

K-Number: K100682 · 2010-07-23

ApplicantWallac OY
Decision Date2010-07-23
Product CodeJLX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U is the device name listed in this FDA 510(k) record. The listed applicant is Wallac OY. It received FDA 510(k) clearance on 2010-07-23 under 510(k) number K100682. 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 GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U?

GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U is a medical device that received FDA 510(k) clearance on 2010-07-23. The listed applicant is Wallac OY. The 510(k) number is K100682.

When did GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U receive FDA 510(k) clearance?

GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U received FDA 510(k) clearance on 2010-07-23, under 510(k) number K100682.

Who is the listed applicant for GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U?

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 GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U?

The FDA product code for GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U is JLX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 KITK081922AUTODELFIA 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-9367K050960MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT

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.

K081922AUTODELFIA 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 OYK042425AUTODELFIA 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.

↑